Co-Diagnostics (NASDAQ: CODX) warns on going concern while advancing PCR platform
Co-Diagnostics, Inc. (CODX) files its annual report describing a specialty PCR diagnostics business while warning of substantial doubt about its ability to continue as a going concern. The company develops lab-based and point-of-care PCR tests, including a Co-Dx PCR Pro platform still awaiting key regulatory clearances.
CODX reports cash and cash equivalents of $11.9 million and an accumulated deficit that widened to $80.4 million, reflecting ongoing losses. It is funding operations through grants and at-the-market equity programs and highlights significant dependence on a few customers and granting agencies. Extensive risk factors cover regulation, competition, supply-chain reliance, data privacy, and the need for additional capital to advance its multiplex respiratory and global infectious disease testing strategy.
Positive
- None.
Negative
- Auditor going concern warning: Recurring losses, an accumulated deficit of $80.4 million, and limited liquidity led auditors to express substantial doubt about CODX’s ability to continue as a going concern, signaling elevated financial and refinancing risk for shareholders.
Insights
CODX combines ambitious PCR platform plans with mounting losses and going concern risk.
Co-Diagnostics is pivoting from single-pathogen COVID-19 testing toward a broader Co-Dx PCR platform and multiplex respiratory panels, backed by grants, joint ventures in India and the MENA region, and growing intellectual property around Co-Primers and point-of-care devices.
Financially, the picture is strained: the accumulated deficit expanded to $80.4 million, cash stood at $11.9 million, and auditors raised substantial doubt about CODX’s ability to continue as a going concern. The company is relying on at-the-market equity sales and grant funding to bridge development and regulatory timelines.
Execution now hinges on obtaining FDA and international clearances for the Co-Dx PCR Pro instrument and associated multiplex tests, while managing concentration in a small number of customers and grantors. Subsequent filings will clarify whether capital raising and regulatory progress materially reduce the going concern uncertainty noted for the period ended December 31, 2025.
Key Figures
Key Terms
Co-Primers technical
Emergency Use Authorization regulatory
at-the-market offering financial
going concern financial
In Vitro Diagnostic Regulation (IVDR) regulatory
HIPAA regulatory
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549.
Form
(Mark One)
For
the fiscal year ended
OR
For the transition period from_______to_______
Commission
File Number
(Exact Name of Registrant as Specified in Its Charter)
(State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer Identification Number) |
(Address of principal executive offices and zip code)
(Registrant’s telephone number including area code)
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||
| The
|
Securities registered pursuant to Section 12(g) of the Act: None
Indicate
by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐
Indicate
by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Act. Yes ☐
Indicate
by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Exchange Act of 1934
during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject
to such filing requirements for the past 90 days.
Indicate
by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data
File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding
12 months (or such shorter period that the registrant was required to submit and post such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
| Large accelerated filer | ☐ | Accelerated filer | ☐ | |
| ☒ | Smaller reporting company | |||
| Emerging growth company |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate
by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness
of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered
public accounting firm that prepared or issued its audit report.
If
securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant
included in the filing reflect the correction of an error to previously issued financial statements.
Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes ☐ No
The
aggregate market value of the voting and non-voting common equity held by non-affiliates computed by reference to the price at which
the common stock was last sold as of the last business day of the registrant’s most recently completed second fiscal quarter was
approximately $
As
of March 29, 2026, there were
Table of Contents
| Page | ||
| PART I | ||
| Item 1. | Business. | 4 |
| Item 1A. | Risk Factors. | 13 |
| Item 1B. | Unresolved Staff Comments. | 23 |
| Item 1C. | Cybersecurity | 24 |
| Item 2. | Properties. | 25 |
| Item 3. | Legal Proceedings. | 25 |
| Item 4. | Mine Safety Disclosures. | 26 |
| PART II | ||
| Item 5. | Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities. | 27 |
| Item 6. | [Reserved.] | 28 |
| Item 7. | Management’s Discussion and Analysis of Financial Condition and Results of Operations. | 28 |
| Item 7A. | Quantitative and Qualitative Disclosures About Market Risk. | 33 |
| Item 8. | Financial Statements and Supplementary Data. | 34 |
| Item 9. | Changes in and Disagreements with Accountants on Accounting and Financial Disclosure. | 55 |
| Item 9A. | Controls and Procedures. | 55 |
| Item 9B. | Other Information. | 56 |
| Item 9C. | Disclosure Regarding Foreign Jurisdictions that Prevent Inspections. | 56 |
| PART III | ||
| Item 10. | Directors, Executive Officers and Corporate Governance. | 56 |
| Item 11. | Executive Compensation. | 61 |
| Item 12. | Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters. | 64 |
| Item 13. | Certain Relationships and Related Transactions, and Director Independence. | 65 |
| Item 14. | Principal Accountant Fees and Services. | 65 |
| PART IV | ||
| Item 15. | Exhibits and Financial Statement Schedules. | 66 |
| 2 |
PART I
Forward-Looking Statements
This Annual Report on Form 10-K contains “forward-looking statements” that involve risks and uncertainties. All statements other than statements of historical fact contained in this Annual Report and the documents incorporated by reference herein, including statements regarding future events, our future financial performance, business strategy, and plans and objectives of management for future operations, are forward-looking statements. We have attempted to identify forward-looking statements by terminology including “anticipates,” “believes,” “can,” “continue,” “could,” “estimates,” “expects,” “intends,” “may,” “plans,” “potential,” “predicts,” “should,” or “will” or the negative of these terms or other comparable terminology. Although we do not make forward looking statements unless we believe we have a reasonable basis for doing so, we cannot guarantee their accuracy. These statements are only predictions and involve known and unknown risks, uncertainties and other factors which may affect our or our industry’s actual results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Moreover, we operate in a highly regulated, very competitive, and rapidly changing environment. New risks emerge from time to time, and it is not possible for us to predict all risk factors, nor can we address the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause our actual results to differ materially from those contained in any forward-looking statements.
We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy, short term and long-term business operations, and financial needs. These forward-looking statements are subject to certain risks and uncertainties that could cause our actual results to differ materially from those reflected in the forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those discussed in this Annual Report, and in particular, the risks discussed under “Item 1, Business,” “Item 1A, Risk Factors,” and “Item 7, Management’s Discussion and Analysis of Financial Condition and Results of Operations,” and those discussed in other documents we file with the Securities and Exchange Commission (the “SEC”). In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed in this Annual Report may not occur as described and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statement.
Important factors that could cause actual results to differ materially from those in the forward-looking statements include, without limitation:
| ● | our ability to obtain regulatory approval to market and sell our products; | |
| ● | the results of clinical evaluations of our product candidates; | |
| ● | market acceptance of any products that may be approved for commercialization; | |
| ● | our ability to protect our intellectual property rights; | |
| ● | the impact of any infringement actions or other litigation brought against us; | |
| ● | competition from other providers and products; | |
| ● | our ability to develop and commercialize new and improved products and services; | |
| ● | changes in government regulation; | |
| ● | and other factors (including the risks contained in the section entitled “Risk Factors” in other documents we file with the SEC) relating to our industry, our operations and results of operations. |
Should one or more of these risks or uncertainties materialize, or should the underlying assumptions prove incorrect, actual results may differ significantly from those anticipated, believed, estimated, expected, intended or planned.
Given these risks and uncertainties, readers are cautioned not to place undue reliance on any forward-looking statements. Forward-looking statements contained in this Annual Report speak only as of the date of this Annual Report. We undertake no obligation to update any forward-looking statements as a result of new information, events or circumstances or other factors arising or coming to our attention after the date hereof.
| 3 |
As used in this Annual Report, the terms “we”, “us”, “our”, “Company”, “CODX” and “Co-Diagnostics” means Co-Diagnostics, Inc., a Utah corporation and its consolidated subsidiaries (the “Company”), unless otherwise indicated.
ITEM 1: BUSINESS
Overview
Co-Diagnostics, Inc., a Utah corporation (the “Company” or “CODX”), develops, manufactures and sells reagents used for diagnostic tests that function via the detection and/or analysis of nucleic acid molecules (DNA or RNA), including molecular tools for detection of infectious diseases. Our diagnostics systems enable dependable, low-cost, molecular testing for organisms and genetic diseases by automating or simplifying historically complex procedures in both the development and administration of tests. CODX’s technical advance involves a novel, proprietary approach to polymerase chain reaction (“PCR”) test design of primer and probe structure (“Co-Primers®”) that dramatically reduces one of the key vexing issues of PCR amplification: the exponential growth of primer-dimer amplification (false positives) which adversely interferes with identification of the target DNA/RNA. Using our proprietary test design system and reagents, we have designed and obtained regulatory approval to sell PCR diagnostic tests for the detection of COVID-19, influenza, tuberculosis, hepatitis B and C, human papillomavirus, malaria, chikungunya, dengue, and the Zika virus. These initial diagnostic tests are cleared for use in clinical labs only and not for point-of-care or at-home use.
We have developed a portable diagnostic device and test system designed for point-of-care and at-home use. The system is comprised of our PCR instrument that we refer to as the Co-Dx™ PCR Pro® instrument, our patent-pending diagnostic test cup system and a mobile application to be installed on the user’s mobile device. We refer to the system as the “Co-Dx™ PCR platform” which has been designed to bring affordable, reliable polymerase chain reaction (“PCR”) testing to patients in point-of-care and at-home settings. The Co-Dx PCR platform is subject to U.S. Food and Drug Administration (“FDA”) review and is not available for sale at the time of this filing. In June 2024, we completed our first FDA application for 510(k) clearance for the Co-Dx PCR Pro instrument, the Co-Dx PCR COVID-19 Test, and the Co-Dx PCR mobile app for over-the-counter (OTC) use. Following engagement with the FDA during the review process, the Company voluntarily withdrew the 510(k) submission after discussions regarding the analytical approach for detecting potential degradation of a test component over its intended shelf life. While the Company believes that the matter identified during the review process could have been addressed through additional development and clinical validation activities, management determined that the capital and time required to resubmit the COVID-19 test for 510(k) clearance would be more effectively deployed toward development and clinical validation of the Co-Dx PCR Flu A/B, COVID-19, RSV multiplex test (“ABCR”). Moving focus to this test allows the Company to incorporate more recent Co-Dx PCR platform developments into the design and test manufacturing process. Management believes that a multiplex test targeting influenza A/B, COVID-19, and RSV better aligns with current clinical demand for comprehensive upper respiratory infection testing in point-of-care settings. Accordingly, clinical performance studies for the ABCR test are currently underway. There is no guarantee that our Co-Dx PCR platform will receive the necessary regulatory approvals for commercialization, or that, if regulatory approval is received, we will be able to successfully commercialize this platform.
| 4 |
Technology
We believe our proprietary and patented molecular diagnostics technology is paving the way for innovation in disease detection and life sciences research through our enhanced detection of genetic material. For various reasons, including owning our own platform, we believe we will be able to accomplish this faster and more economically than some competitors, allowing for significant margins while still positioning ourselves as a low-cost provider of molecular diagnostics and screening services. For example, we were the first US-based company to receive a CE-marking for a COVID-19 test in early 2020, as we worked to help slow the spread of the pandemic through our global network of distributors covering clinical labs in more than 50 countries. Our Logix Smart® COVID-19 test was designed, developed, submitted for regulatory approval and ready to be used as an in vitro diagnostic (“IVD”) in countries that accept CE marking for regulatory clearance in a period of just over 30 days. This is a real-world example of how CODX technology can be used in an evolving epidemic or pandemic to get diagnostic tools in the hands of medical professionals in a timely manner. It can be similarly used to design a test for mutated strains of SARS-CoV-2 or other viruses should they not be detectable using currently available tests.
In addition, continued development has demonstrated the unique properties of our Co-Primers technology that we believe makes it ideally suited for a variety of applications where specificity is key to optimal results, including multiplexing several targets, enhanced Single Nucleotide Polymorphism (“SNP”) detection and enrichment for next generation sequencing.
Our scientists use the complex mathematics of DNA/RNA PCR test design to engineer and optimize PCR tests and to automate algorithms that rapidly screen millions of possible options to pinpoint the optimum design. The intellectual property we use in our business consists of the predictive mathematical algorithms and patented molecular structure used in the testing process, which together represent a major advance in PCR testing systems. CODX technologies are now protected by more than 20 granted or pending US and foreign patents, as well as certain trade secrets and copyrights. Ownership of our proprietary platform permits us the advantage of avoiding payment of patent royalties required by other PCR test systems, which may allow for the sale of diagnostic PCR tests at a lower price than competitors, while enabling us to maintain profit margins.
Our proprietary test design process involves identifying the optimal locations on the target genes for amplification and pairing the locations with the optimized primer and probe structure to achieve outputs that meet the design input requirements identified from market research. This is done by following planned and documented processes, procedures and testing. In other words, we use the data resulting from our tests to verify whether we succeeded in designing what we intended. Verification involves a series of testing that concludes that the product is ready to proceed to validation in an evaluation either in our laboratory or in an independent laboratory setting using initial production tests to confirm that the product as designed meets the user’s needs.
Using our proprietary test design system and reagents, we have designed and obtained regulatory clearance in the European Community and in India (along with our joint venture, CoSara) to sell PCR diagnostic tests for the detection of COVID-19, influenza, tuberculosis, hepatitis B and C, human papillomavirus, malaria, chikungunya, dengue, and the Zika virus. In the United States, we obtained Emergency Use Authorization (“EUA”) for our Logix Smart® COVID-19 detection test from the FDA, and we sell that test to qualified labs. In addition, our COVID-19 detection test and certain of our other suite of COVID-19 products have been cleared for sale in countries such as the United Kingdom, Australia, India, and Mexico by the regulatory bodies in those countries and have been registered for sale in many more countries. In connection with the sale of our tests we may sell diagnostic equipment from other manufacturers, including an OEM’s PCR instrument which we refer to here as the “Co-Dx Box™”.
In addition to testing for infectious diseases, Co-Primers technology lends itself to identifying any section of a DNA or RNA strand that describes any type of genetic trait, which creates several significant applications. We, in conjunction with our customers, have designed tests that identify genetic traits in plant and animal genomes. We also have commercialized three multiplexed tests to test mosquitos for the presence of diseases they carry, which enables municipalities to concentrate their efforts in managing mosquito populations in specific areas where mosquitos carrying deadly viruses are known to breed.
| 5 |
Co-Dx PCR Platform
We believe the benefits of affordable, high-quality diagnostics should be available to everyone. High-quality point-of-care polymerase chain reaction (“PCR”) testing plays a crucial role in healthcare. It enables rapid diagnosis of infectious diseases, such as COVID-19, influenza or tuberculosis, facilitating timely treatment and containment measures. By delivering results on-site, it eliminates the need for sample transportation, reducing the risk that the sample is transported incorrectly or lost, reducing turnaround time to results, and allowing for immediate decision-making. Gold-standard PCR testing at the point of care ensures reliable detection of pathogens, minimizing incorrect results. In short, high-quality PCR testing at home and at the point of care enhances patient care, public health response, and helps control the spread of infectious diseases. That is why we have developed the Co-Dx PCR platform utilizing our Co-Primers® real-time PCR technology for at-home and point-of-care testing. Because we believe that testing for upper respiratory and other infectious diseases will continue to be a consideration for public health worldwide, we initiated the Co-Dx PCR platform to facilitate frequent, affordable, reliable PCR testing to patients in point-of-care and at-home settings, including schools, businesses, pharmacies and the hospitality industry. Our Co-Dx PCR Pro platform is comprised of a compact, relatively low-cost testing device, the Co-Dx PCR Pro instrument, together with diagnostic test cups that work with the instrument, and an intuitive mobile application that is easy to use by professionals and non-professionals, all of which can provide PCR test results in around 30 minutes. As user test results are analyzed and anonymized in the cloud, we believe this data may be useful for governmental health agencies and the World Health Organization to determine where outbreaks of infectious diseases may be occurring and to enable them to act more quickly and efficiently to slow-down or perhaps even prevent further spread.
The 6 ½” x 4 1/2” x 6”, 2 lbs. Co-Dx PCR Pro instrument operates via a smartphone app with simple-to-follow instructions that includes videos to walk users through every step, from sample swab collection to the straightforward instrument operation. Results are processed in the cloud and delivered back to the user’s smartphone or tablet in about 30 minutes using software designed from the ground-up for this specific use. The PCR tests themselves (contained in the simple but unique, innovative test collection cups) are powered by patented Co-Dx Co-Primers PCR technology.
The initial diagnostic test designed for use on this platform, an at-home and point-of-care COVID-19 PCR test, was ultimately facilitated by our development of a saliva or nasal swab-based PCR test that does not require RNA/DNA extraction (standard in laboratory-based PCR testing). The final result was believed to be approximately equivalent to those processed by a high-complexity clinical laboratory. Our COVID-19 PCR platform test had the advantages of increased speed over clinical laboratories, with results in around 30 minutes compared to hours or even days, and ease of handling thanks to lyophilization (or freeze-drying) of our testing reagents to allow for storage at room temperatures. In December 2023, we submitted our proprietary Co-Dx PCR COVID-19 test cups, together with the Co-Dx PCR Pro instrument and mobile application, all designed for use in point-of-care and at-home settings, for review by the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA). In June 2024, we completed our first FDA application for 510(k) clearance for the Co-Dx PCR Pro instrument, the Co-Dx PCR COVID-19 Test, and the Co-Dx PCR mobile app for over-the-counter (OTC) use. Following engagement with the FDA during the review process, the Company voluntarily withdrew the 510(k) submission after discussions regarding the analytical approach for detecting potential degradation of a test component over its intended shelf life. While the Company believes that the matter identified during the review process could have been addressed through additional development and clinical validation activities, management determined that the capital and time required to resubmit the COVID-19 test for 510(k) clearance would be more effectively deployed toward development and clinical validation of the Co-Dx PCR Flu A/B, COVID-19, RSV multiplex test (“ABCR”). Moving focus to this test allows the Company to incorporate more recent Co-Dx PCR platform developments into the design and test manufacturing process. Management believes that a multiplex test targeting influenza A/B, COVID-19, and RSV better aligns with current clinical demand for comprehensive upper respiratory infection testing in point-of-care settings. Accordingly, we announced on November 17, 2025 that the clinical performance studies for the ABCR test were underway. There is no guarantee that our Co-Dx PCR platform will receive the necessary regulatory approvals for commercialization, or that, if regulatory approval is received, we will be able to successfully commercialize this platform.
In July 2023 we were awarded $1.2 million in funding from the National Institutes of Health (NIH) as part of the Rapid Acceleration of Diagnostics (RADx®) Tech program for development of our upper respiratory panel diagnostic test for use on the Company’s Co-Dx PCR platform. We have utilized the funds from the RADx Tech award to complete development of our flu A/B, COVID-19, and RSV multiplex test, in preparation for the clinical performance testing on the Co-Dx PCR Pro instrument, which began in November 2025. The NIH launched the RADx initiative on April 29, 2020, with the goal of speeding innovation in the development, commercialization, and implementation of technologies for COVID-19 testing, leveraging the existing NIH Point-of-Care Technology Research Network. The RADx Tech program is managed by the National Institute of Biomedical Imaging and Bioengineering (NIBIB), to support the accelerated development of tests and provide regulatory guidance during the COVID-19 pandemic and beyond.
| 6 |
We are also developing diagnostics tests for TB and HPV for use with our Co-Dx PCR platform. We have been awarded two grants totaling $6.8 million for the TB test and one grant totaling $987,000 for the HPV test by the Bill & Melinda Gates Foundation to support the development and manufacture of these tests for our Co-Dx PCR platform. In 2014, all United Nations Member States and the World Health Organization (WHO) committed to ending the global TB epidemic by 2030, before the COVID-19 pandemic slowed, stalled or reversed progress of global TB targets. The WHO reported a worldwide gap of roughly 2.4 million unidentified cases between the reported number of newly diagnosed TB cases in 2024 and the estimated number of incident cases, highlighting the need for a dramatic increase of affordable, high-quality, point-of-care TB diagnostics to enable rapid treatment decisions to be made for a disease that has a mortality rate of about 50% if left untreated. The National Cancer Institute estimates that high-risk HPVs cause roughly 5% of all cancers worldwide, including cervical cancer, the fourth most common cancer in women and which led to an estimated 350,000 cervical cancer deaths in 2022 according to the WHO. About 94% of these deaths are in low- and middle-income countries, and all of which the WHO believes can be dramatically reduced by access to diagnostics, vaccinations, and cancer screenings.
Infectious Disease Product Offering
Using our proprietary test design system and patented Co-Primers, we and CoSara Diagnostics Pvt Ltd (“CoSara”), our joint venture for development and manufacturing in India, design and sell PCR diagnostic tests for detection of diseases and pathogens such as COVID-19, influenza, tuberculosis, hepatitis B and C, malaria, dengue, human papillomavirus, chikungunya, and Zika virus, all of which tests have been designed and verified in our laboratories. The Co-Dx Logix Smart® Mycobacteria Tuberculosis (MTB) test and Logix Smart Zika test received CE marking in 2018, and for the Logix Smart Zika, dengue and chikungunya (ZDC) multiplex test received CE marking in 2019, qualifying the tests to be sold throughout the European community and in most countries in Central and South America (subject to local registration requirements). In December 2019, CoSara received a license from the Central Drugs Standard Control Organization (“CDSCO”) to manufacture and sell tuberculosis, hepatitis B, hepatitis C, human papillomavirus 16/18 and malaria tests in India. In February 2020, we received CE marking for our Logix Smart COVID-19 test followed by an EUA by the FDA in April 2020. Also, in April 2020, our COVID-19 test was approved for manufacture and sale in India by the CDSCO and in Mexico by the INDRE, Mexico’s equivalent to the United States Center for Disease Control. In August 2020, we received approval from the Australian Department of Health Therapeutic Goods Division to sell our COVID-19 test in Australia.
As explained above, our Logix Smart COVID-19 test was designed, developed, submitted for regulatory clearance and ready to be used as an in vitro diagnostic (“IVD”) in countries that accept CE marking for regulatory clearance in a period of just over 30 days. This is a real-world example of how CODX technology can be used in an evolving epidemic or pandemic to get diagnostic tools in the hands of medical professionals in a timely manner. It can be similarly used to design a test for mutated strains of SARS-CoV-2 or other viruses should they not be detectable using currently available tests.
Caribbean and Central and South America
We began selling PCR diagnostic tests to entities located in South and Central America and the Caribbean in 2018. In some of those countries, there are limited regulatory hurdles, which allowed us to begin offering our tests immediately with CE markings. We have applied for and received registrations for our tests in many of those countries that require registration, and our distributors in those countries have provided us with in-country assistance in completing such registrations.
We first offered our Zika test in this region because of the demand for such a test at that time, followed by tests for tuberculosis, and our triplex test for Zika, chikungunya, and dengue. Sales of those tests have been modest, but with the granting of CE marking and EUA for our Logix Smart COVID-19, we experienced an increase in sales in this region.
India
In January 2017, the Company entered into an agreement to manufacture diagnostics tests for seven infectious diseases with a pharmaceutical manufacturing company in India and formed CoSara Diagnostics Pvt. Ltd. as a joint venture. The agreement provided for the construction of a manufacturing plant, the manufacture of the PCR tests using the Company’s primer technology, and the joint sales and marketing of those tests in India. We have received a license for the plant in Ranoli, India to manufacture approved tests and it is being used for testing and manufacturing of our products for the Indian market.
The CDSCO has issued clearances for 15 laboratory-based PCR tests to be sold by CoSara as IVDs, and the Company’s joint venture manufactures and sells 14 of those tests under the SaraGene brand. The Company manages a reagent rental program in India with thermocyclers purchased from a third-party manufacturer, the Co-Dx Box. The placement of thermocyclers in India has facilitated the sale of the SaraGene PCR tests in India. The WHO 2025 Global Tuberculosis Report indicates that India was the country with the highest number of cases of tuberculosis in the world in 2024, with 25% of an estimated global incidence of approximately 10.7 million cases.
| 7 |
CoSara received authorization to manufacture and sell COVID-19 tests in India. Those tests in India are branded as SaraGene COVID-19 tests and are sold exclusively by CoSara. The Indian government places restrictions on the price that could be charged for COVID-19 tests which limited the revenue in India more than we experienced in other parts of the world. At the time of this report, CoSara has received CDSCO clearance for RT-PCR tests for Mycobacterium tuberculosis, malaria, hepatitis B, hepatitis C (including viral load tests for both hepatitis B and C), human papillomavirus (HPV), a test for high-risk HPV, two COVID-19 assays, chikungunya, dengue, a dengue/chikungunya duplex test, an influenza A/influenza B/COVID-19 (“ABC”) multiplex test, and in 2024 CDSCO cleared the manufacture and sale of the SARAPLEX™ Influenza Multiplex (IFM) Test Kit to clinical laboratories as an in vitro diagnostic for the detection and differentiation of Influenza A and Influenza B. Additionally, in 2026, CoSara received a license from CDSCO to manufacture the CoSara PCR Pro® real-time PCR point-of-care instrument for sale or distribution.
Europe
Molecular diagnostics, such as our tests, are governed in Europe by the framework for IVDs, which encompasses diagnostic products such as reagents, instruments and systems intended for use in diagnosis of disease. The regulatory system for some IVDs historically allowed for a self-certification procedure, placing heavy responsibility on manufacturers. Non self-certified products were subject to the same standards as self-certified products but were also subject to audit and review by a notified body prior to receiving approval to receiving CE marking. A CE-marking is a manufacturer’s declaration that a product meets the requirements of the applicable European Commission (EC) directive. Examples of current obligations include having in place a qualitative manufacturing process, user instructions that are clear and fit for purpose, and ensuring that the ‘physical’ features of devices and diagnostics do not pose any danger. If a product fulfils these and other related control requirements, it may bear a CE marking, as an indication that the product is compliant with EU legislation and sold in the European Union. We have received CE markings for six of our tests including for COVID-19, COVID-19 (2 gene test), ABC (a triplex test for Flu A, Flu B and COVID-19), a DS (Direct Saliva, extraction-free) COVID-19 test, tuberculosis, Zika, and our Zika, dengue, chikungunya triplex tests. In May 2022, the In Vitro Diagnostic Regulation (IVDR), a new regulation that significantly revised the requirements for CE marking of IVDs, became effective. To avoid potential shortages of essential healthcare products, the EC extended the transition deadlines in 2024. Co-Dx is actively pursuing CE-IVD compliance under IVDR through the Annex IX route to conformity. For manufacturers actively pursuing IVDR compliance, European regulators have allowed a grace period until 2029 for Class B devices to harmonize their devices and Quality Management Systems (QMS) with the new regulation.
Co-Diagnostics PCR tests are manufactured under an ISO 13485:2016 certified quality management system, relating to the design and manufacture of our medical device products. The ISO certification indicates that we meet the standards required to pursue CE-marking for certain of our products, subject to the requirements in the updated directive mentioned above.
KSA/MENA Region
In October 2025, we entered into a definitive agreement with Arabian Eagle Manufacturing, a regional manufacturing and distribution company based in the Kingdom of Saudi Arabia (“KSA”) to form CoMira Diagnostics (“CoMira”), a joint venture dedicated to research, develop, manufacture, assemble, distribute, and commercialize Co-Dx technologies and intellectual property, including the Company’s upcoming Co-Dx™ PCR point-of-care platform, within KSA and 18 other countries throughout the Middle East and North Africa (“MENA”). CoMira’s mission aligns with the key pillars of Saudi Vision 2030, supporting technology localization, industrial diversification, and healthcare innovation, as the new venture engages in research, development, manufacturing, assembly, distribution, and commercialization of Co-Dx products. CoMira believes that initially pursuing regulatory clearance with the Saudi Food & Drug Administration (“SFDA”) will also directly facilitate entry into many of the other 18 MENA countries included in the agreement, consisting of: Bahrain, Iraq, Jordan, Kuwait, Lebanon, Oman, Palestine, Qatar, Syria, Turkey, United Arab Emirates (UAE), Yemen, Algeria, Egypt, Libya, Morocco, Sudan and Tunisia
Arabian Eagle was the Company’s primary distributor in the Middle East and was instrumental in KSA being one of the largest international markets for the Company’s Logix Smart® tests. Similar to the Company’s partnership in India with CoSara, Co-Dx will provide CoMira an exclusive license to use, manufacture, and commercialize the licensed IP, which will include the upcoming Co-Dx PCR platform as well as the Company’s existing suite of lab-based PCR diagnostic products. We believe that our cutting-edge PCR technology, along with the scope and mission of CoMira, addresses the key demand drivers for growth published by KSA while reinforcing our resolve to close the accessibility gap between high-quality PCR diagnostics and those who need them.
United States
Section 801(e) of the Federal Food, Drug, and Cosmetic Act, as amended (the “FDA Act”) covers certain medical devices that have not yet received an approved Premarket Approval in the United States by the FDA, such as our products. We have not commenced any premarket approval of 510(k) submission steps with the FDA for any of our Logix Smart PCR tests. Section 801(e) of the FDA Act applies to medical devices that are acceptable to the importing country and that are manufactured under the FDA’s Good Manufacturing Practices, and grants Co-Diagnostics permission to export all of our IVD products. We have received EUA clearance for our Logix Smart COVID-19 test, which allows sales to qualified labs in the United States and facilitates the registration for sale in other countries as well. We intend to pursue all appropriate FDA review pathways for products under development, including traditional premarket review pathways.
Under our EUA, we continue to sell our Logix Smart COVID-19 test to overseas customers and to CLIA certified laboratories in the United States. The CLIA labs are able to use our test, or to further validate our COVID-19 tests (or other tests) as Laboratory Developed Tests (LDTs), which refers to a diagnostic test that has been validated for use in the CLIA lab. LDTs may be used by the lab only in that laboratory. CLIA laboratories develop the performance characteristics, perform the analytical validation for their LDTs and obtain licenses to offer them as diagnostic services. We are currently marketing our Logix Smart COVID-19 test to CLIA laboratories throughout the US.
| 8 |
Market Opportunity
The market opportunity for our tests changed radically with the emergence of the COVID-19 pandemic. Because we were able to respond rapidly and produce a quality product, we have been able to build a worldwide distribution network that has allowed us to export products throughout the world. We anticipate that our network of distributors that we have built over the past six years will serve us well in sales and distribution of other diagnostic tests and our forthcoming PCR diagnostic platform.
The molecular diagnostics market is a fast-growing portion of the in vitro (test tube-based, controlled environment) diagnostics market. There are several advantages of PCR tests over other forms of diagnostic testing. These advantages include higher specificity and sensitivity, the ability to perform multiplex tests and the ability to test for drug resistance or for individual genes.
Mosquito Vector Control Services
In response to market demand, in June 2019 we introduced our first Vector Smart® PCR tests to be used exclusively for mosquito-borne pathogens in mosquito populations. Municipalities in the US and many other countries in the world are concerned about the infections carried by mosquitos, which infect the human population. To prevent outbreaks of potentially harmful viruses such as Zika or West Nile from infecting the public, many municipalities conduct mitigation operations to eliminate the mosquito populations carrying the diseases. Because it is too expensive and potentially harmful to the environment to treat all mosquito breeding areas, municipalities may identify and focus their efforts on particular areas with mosquitos that are carrying these harmful viruses. To know where the host mosquitos with harmful viruses are located, traps are set, mosquitos collected and then tested. There are over 3,000 mosquito abatement districts throughout the United States and almost all of them conduct testing to help make the spraying more effective.
Our first vector related test was the Vector Smart NAM-w triplex test for West Nile, western equine encephalitis and St. Louis encephalitis. We began shipping the tests in June 2019. We added a second test that tests mosquitos for Zika, chikungunya and dengue in a triplex test. Finally, in November 2019, we completed the Vector Smart NAM-e test for West Nile, eastern equine encephalitis and St. Louis encephalitis, specifically for use in the eastern United States. As a result, mosquito abatement districts can test for three target viruses in one test as compared to performing three different tests using other market available tests. Our products also allow municipalities to obtain test results in-house in a matter of hours, instead of the days or weeks they might otherwise have to wait for a central lab to process the mosquito tests.
We have sold our Vector Smart test products and/or related lab equipment to testing districts in different sections of the country and are marketing our products through trade shows, electronic and regular mail solicitations.
| 9 |
Competitive Advantages of Co-Diagnostics
We believe that we have the following competitive advantages:
| ● | Affordability: Lower-cost test kits, a low-cost Co-Dx Box, and an affordable Co-Dx PCR platform for at-home and point-of-care testing (the platform is subject to FDA review and not available for sale at the time of this filing). | |
| ● | Flexibility: CODX’s lab-based tests have been designed to run on many customers’ DNA/RNA diagnostic testing machines. Our technology is well suited to the new generation of point-of-care testing (POCT), compact and portable analysis machinery for field, clinical and office applications. | |
| ● | Speed: We believe our rapid assay design system software provides shorter time to product release. This has been demonstrated with the conception, design, product manufacture, clinical verification and submission for a CE marking for our Logix Smart COVID-19 test (under the previous directive) being approximately 30 days. | |
| ● | Accuracy: We believe our technology allows us to build tests that are highly sensitive and specific, the two benchmarks for accuracy in PCR testing. | |
| ● | Personalized Medicine: We project that rising health care costs in developed and developing nations will increasingly require that health care systems be patient-specific to eliminate waste, misdiagnoses, and ineffectiveness. A critical component will be accurate, more affordable molecular diagnostics, especially in at-home and POCT settings. | |
| ● | Low-Cost Provider: Our platform technology obviates the need to pay certain patent royalties typically required of our competitors, which use third-party patented test platforms to design and manufacture their tests. | |
| ● | Worldwide Footprint: With a dynamic technology that encompasses markets worldwide, we anticipate that we can identify the best target markets, not only in low-to-middle income countries but also in developed nations. | |
| ● | Data Collection: With the anticipated deployment of the Co-Dx PCR platform we expect to play a role in decentralized diagnostics, while centralizing global data collection on infectious diseases that may contribute to faster vaccination and therapeutic responses from health authorities. | |
| ● | Growth Industry Category: We believe that real-time PCR testing is the fastest-growing segment of in vitro diagnostic testing. | |
| ● | Combination Product Offering: Our tests can be a well-designed match for a new generation of compact and other small POCT devices now entering the market, including our own Co-Dx Box and Co-Dx PCR Pro instrument. Used together, we believe these affordable tests and devices have the potential to revolutionize the molecular diagnostics industry in cost, speed of test results and simplification. | |
| ● | Multiplexing: Our existing multiplexed tests demonstrate that our Co-Primers-designed tests are able to test for multiple targets in the same sample without the distortion caused by false positives that often occur in multiplexed tests. |
| 10 |
Intellectual Property
Much of our future success and value depends on our proprietary technology, and therefore, our patent and intellectual property strategy is of critical importance. Currently, our flagship Co-Primers technology is covered by two U.S. patents titled “Cooperative primers, probes, and applications thereof” as well as by granted and pending foreign counterparts. We have another three U.S. patents directed to our earlier work in primer and assay designs. For more recent works, we have filed international and U.S. patent applications directed to “Methods and Compositions for Next Generation Sequencing (NGS) Library Preparation,” “Allele-Specific Design of Cooperative Primers for Improved Nucleic Acid Variant Genotyping,” “Methods and Compositions Related to Cooperative Primers and Reverse Transcription,” and “Systems, Methods, and Apparatus for Automated Self-Contained Biological Analysis” which is the basis of the Co-Dx at-home and point-of-care PCR platform. In December 2025 we announced the first patent received for this platform, granted by Australia (Patent No. AU2022270084A1). This was followed by the announcement in March 2026 that the Japan Patent Office had granted Patent No. 7797537, titled “Systems, Methods, and Apparatus for Automated Self-Contained Biological Analysis,” which includes 34 claims covering the fundamental systems, methods, and apparatus of the Co-Dx PCR Pro® instrument and proprietary test cups designed for use with the system. We intend to continue building our patent portfolio as development continues and resources are available.
We also protect some of our technology and know-how as trade secrets and, where appropriate, we use and register trademarks to protect and strengthen our products and proprietary brands. All trademarks, trade/product names, graphics and logos of Co-Diagnostics contained herein are trademarks of Co-Diagnostics or its subsidiary, as applicable, in the U.S. and/or other countries. Solely for convenience, we may refer to trademarks in this Annual Report on Form 10-K without the ™ or ® symbols, but such references are not intended to indicate, in any way, that we will not assert, to the fullest extent permitted by law, our rights to our trademarks.
Major Customers
The Company had certain customers which were each responsible for generating 10% or more of revenue for the years ended December 31, 2025 and 2024, respectively. One customer accounted for approximately 31% of product revenue for the year ended December 31, 2024. One granting agency accounted for 100% of grant revenue for the year ended December 31, 2025, and two granting agencies accounted for approximately 95% of grant revenue for the year ended December 31, 2024. These customers and granting agencies may not account for the same percentage of product revenue or grant revenue in future periods. If we were to sell nothing to those customers in the future, it would have a material adverse effect on our financial condition unless we were able to replace those customers with others.
Competition
The molecular diagnostics industry is extremely competitive. There are many firms that provide some or all of the products we provide and provide many diagnostic tests that we have yet to develop. Many of these competitors are larger than us and have significantly greater financial resources. Many of our competitors have a competitive advantage in the diagnostic testing industry because they also have other lines of business in the diagnostics, pharmaceutical, or biotech industries from which they derive revenues and for which they are well known and respected in the medical profession. Many of these competitors already have an established customer base with industry standard technology, which we must overcome to be successful. In the diagnostic testing and POCT industries, we compete with such companies as BioMerieux, Siemens, Qiagen, Roche Diagnostics and Cepheid and with such pharmaceutical companies as Abbott Laboratories, Becton Dickinson and Johnson and Johnson. We also compete with companies from Asia in certain markets who are willing to sell their tests for much less than we sell our tests, which creates competitive price pressure on us in certain regions, particularly Asia and Latin America.
| 11 |
We expect competition to continue to increase as other established and emerging companies enter the market, as customer requirements evolve, and as new products, services and technologies are introduced. Some of our existing or new competitors may have strong relationships with current and potential customers, including governmental authorities, and, as a result, may be able to respond more quickly to new or changing regulatory requirements, new or emerging technologies, and changes in customer requirements.
Government Regulation
In the United States, we are regulated by the FDA and our products must be approved, cleared, or authorized by the FDA before we are allowed to sell our tests in the United States as in vitro diagnostics. The FDA granted us an EUA to manufacture and sell our Logix Smart COVID-19 test to CLIA labs in the United States. The Company operates under an ISO 13485:2016 certified quality management system, relating to the design and manufacture of our medical device products. Being ISO certified greatly facilitates our applications for regulatory clearance, including CE marking, which allows us to sell any tests in most countries in Europe, South America and Asia, depending on the country and following that country’s registration process. We currently have CE markings issued for our Logix Smart COVID-19 test, tuberculosis test, Zika virus test, a Zika, dengue, and chikungunya multiplex test, a triplex “ABC” test that identifies and distinguishes between Flu A, Flu B and Covid-19, our SARS-CoV-2 2-gene multiplex test, and our DS (Direct Saliva, extraction-free) COVID-19 test. In addition, our Logix Smart COVID-19 has received the required license to manufacture and sell in India from India’s CDSCO, and The National Epidemiology Institute in Mexico evaluated our Logix Smart COVID-19 and ABC tests and approved them for sale in Mexico. We have also received clearance to sell our Logix Smart COVID-19 test in Australia.
Employees
As of December 31, 2025, we had 115 full-time and part-time employees at our executive offices and lab facilities in Salt Lake City, Utah. We have engaged independent contractors to promote the use of our products and develop outlets for products and employ the services of independent sales representatives on an “as needed” basis.
We consider our people and the way we work to support each other and serve our customers to be critical to our success. The key human capital measures and objectives that we focus on in managing our business are maintaining a strong and collaborative company culture, increasing our diversity, inclusion and belonging, offering fair and competitive compensation and benefits, investing in people and organizational development, protecting and enriching employee health and wellness, and sustaining a culture of respectful and effective communications.
Organizational History and Corporate Information
We were incorporated as Co-Diagnostics, Inc., in Utah on April 18, 2013. Our principal executive office is located at 2401 S. Foothill Drive, Salt Lake City, Utah 84109. Our telephone number is (801) 438-1036. Our web address is www.codiagnostics.com. The contents of our website are not incorporated by reference in this Annual Report.
| 12 |
ITEM 1A. RISK FACTORS
Risks Related to Our Business and Industry
We have limited commercial history upon which to base our prospects and are not certain that we will achieve profitability in the future.
We have a limited operating history. We began operations in April 2013. Our accumulated deficit was $80.4 million and $33.5 million as of December 31, 2025 and 2024, respectively. We do not have any way of predicting when or if we will achieve profitability in the future. Potential investors should be aware of the difficulties normally encountered by early commercial stage companies, many of which are beyond our control, including substantial risks and expenses in the course of developing new diagnostic tests, obtaining regulatory approval of clearance to commercialize such tests, establishing or entering new markets, organizing operations and marketing procedures. The likelihood of our success must be considered in light of these risks, expenses, complications and delays, and the competitive environment in which we operate. There is, therefore, nothing at this time upon which to base an assumption that our business plan will prove successful, and we may not be able to generate significant revenue, raise additional capital or operate profitably. We will continue to encounter risks and difficulties frequently experienced by early commercial stage companies, including scaling up our infrastructure and headcount, and may encounter unforeseen expenses, difficulties or delays in connection with our growth. In addition, as a result of the start-up nature of our business, we expect to continue to sustain substantial operating expenses and may not be able to continue generating sufficient revenues to cover expenditures. Any investment in our company is therefore highly speculative and could result in the loss of any investment.
Our future success is dependent on our development of our Co-Dx PCR platform and securing regulatory approval for the platform including the PCR Pro instrument and related diagnostic tests, demand for infectious disease diagnostics and upon our ability to develop and market other commercially accepted diagnostic tests for our PCR platform.
Our future success will depend, in part, on our development of our Co-Dx PCR platform and securing regulatory approval for the platform including the PCR Pro instrument and related diagnostic tests, our ability to develop and sell sufficient quantities of other diagnostics tests, and our ability to successfully and profitably market our Co-Dx PCR platform. Attracting new customers and distribution networks requires substantial time and expense. Any failure to obtain regulatory approval for our product candidates and to increase sales of our diagnostic tests in sufficient quantities to achieve profitability in a timely manner would adversely affect our operating results. Many factors could affect the market acceptance and commercial success of any of our diagnostic tests and devices, including:
| ● | Our ability to develop additional infectious disease diagnostic tests for which there is a commercial market; | |
| ● | Our ability to obtain regulatory clearance to commercialize our product candidates; | |
| ● | our ability to convince our potential customers of the advantages and economic value of our tests over competing technologies and diagnostic tests; | |
| ● | the breadth of our test menu relative to competitors; | |
| ● | changes to policies, procedures or currently accepted best practices in clinical diagnostic testing; | |
| ● | the extent and success of our marketing and sales efforts; and | |
| ● | our ability to manufacture in quantity our commercial diagnostic tests and meet demand in a timely fashion. |
| 13 |
The diagnostic market is highly competitive, and we may not be able to compete effectively against the larger, well-established companies that dominate this market or emerging and small innovative companies that may seek to obtain or increase their share of the market.
The markets for diagnostic products are intensely competitive, and many of our competitors are much larger and have substantially more financial and human resources than we do. Many have long histories and strong reputations within the industry, and a relatively small number of companies dominate these markets.
These companies enjoy significant competitive advantages over us, including:
| ● | broad product offerings, which address the needs of health care providers in a wide range of applications; | |
| ● | products that are supported by long-term clinical data; | |
| ● | greater experience in, and resources for, launching, marketing, distributing and selling products, including strong sales forces and established distribution networks; | |
| ● | extensive intellectual property portfolios and greater resources for patent protection; | |
| ● | greater financial and other resources for product research and development; | |
| ● | greater experience in obtaining and maintaining FDA and other regulatory clearances and approvals for products and product enhancements; | |
| ● | established manufacturing operations and contract manufacturing relationships; | |
| ● | significantly greater name recognition and widely recognized trademarks; and | |
| ● | established relationships with healthcare providers and payers. |
Our products and any product candidates that we may introduce into the market may not enable us to overcome the competitive advantages of these large and dominant companies. In addition, even if we successfully introduce additional product candidates into the market, emerging and small innovative companies may seek to increase their market share and they may eventually possess competitive advantages, which could adversely impact our business. Our competitors may also employ pricing strategies that could adversely affect the pricing of our products.
We depend on a limited number of third-party suppliers for key raw materials used in the manufacturing of our products, and the loss of these third-party suppliers or their inability to supply us with adequate raw materials could harm our business.
We rely on a limited number of third-party suppliers for the raw materials required for the production of our diagnostic products and product candidates. Our dependence on a limited number of third-party suppliers involves several risks, including limited control over pricing, availability, quality, and delivery schedules for raw materials. We have no supply agreements in place with any of our suppliers and cannot be certain that our current suppliers will continue to provide us with the quantities of raw materials that we require or that satisfy our anticipated specifications and quality requirements. Any supply interruption in limited or single sourced raw materials could materially harm our ability to manufacture our products until a new source of supply, if any, could be identified and qualified. We may be unable to find a sufficient alternative supply channel within a reasonable time or on commercially reasonable terms. Any performance failure on the part of our suppliers could delay the production of our products and product candidates and delay the development and commercialization of our product candidates, including limiting supplies necessary for commercial sale, clinical trials and regulatory approvals, which could have a material adverse effect on our business.
In order to be successful, we must expand our available product lines by commercializing new product candidates, but we may not be able to do so in a timely fashion and at expected costs, or at all.
Although we are currently manufacturing diagnostic kits for commercialization, in order to be successful, we will need to expand our product lines to include other diagnostic products. To succeed in our commercialization efforts, we must effectively continue product development and testing, find new strategic partners, obtain regulatory clearances and approvals, and enhance our sales and marketing capabilities. Because of these uncertainties, there is no assurance that we will succeed in bringing any of our current or future product candidates to market. If we fail in bringing our product candidates to market, or experience delays in doing so, we will not generate revenues as planned and will need to curtail operations or seek additional financing earlier than otherwise anticipated.
We are dependent on our senior management team, scientific team, and external advisors, and the loss of any of them could harm our business, including by adversely affecting our ability to effectuate our business strategy.
The members of our current senior management team may not be able to successfully implement our strategy. In addition, we have not entered into employment agreements with any of the members of our senior management team. There are no assurances that the services of any of these individuals will be available to us for any specified period of time. The successful integration of our senior management team, the loss of members of our senior management team, scientific team and key external advisors, or our inability to attract or retain other qualified personnel or advisors could have a material adverse effect on our business, financial condition and results of operations. We may not have a sufficient number of qualified personnel to effectuate our business strategy, which could have a material adverse effect on our business, financial condition and results of operations.
| 14 |
If we experience significant disruptions in our information technology systems, our business, results of operations and financial condition could be adversely affected.
The efficient operation of our business depends on our information technology systems. We rely on our information technology systems to effectively manage our sales and marketing, accounting and financial functions; manufacturing processes; inventory; scientific and product development functions; and our research and development functions. As such, our information technology systems are vulnerable to damage or interruption including from earthquakes, fires, floods and other natural disasters; terrorist attacks and attacks by computer viruses or hackers; power losses; and computer systems, or Internet, telecommunications or data network failures. The failure of our information technology systems to perform as we anticipate or our failure to effectively implement new systems could disrupt our entire operation and could result in decreased sales, increased overhead costs, excess inventory and product shortages, all of which could have a material adverse effect on our reputation, business, results of operations and financial condition.
Cybersecurity risks and the failure to maintain the integrity of company, employee or customer data could expose us to data loss, litigation and liability, and our reputation could be significantly harmed.
We and third-party service providers collect and retain large volumes of data, including personally identifiable information regarding clinical trial participants and others, for business purposes, including for regulatory, research and development and commercialization purposes, and our collaborators’ various information technology systems enter, process, summarize and report such data. We also maintain personally identifiable information about our employees. The integrity and protection of our company, employee and clinical data is critical to our business. We are subject to significant data security and privacy laws and regulations. These regulations impose significant requirements on how we maintain, use, and protect such information. Maintaining compliance with these evolving regulations and requirements could be difficult and may increase our expenses. In addition, a penetrated or compromised data system or the intentional, inadvertent or negligent release or disclosure of data could result in theft, loss or fraudulent or unlawful use of company, employee or clinical data which could harm our reputation, disrupt our operations, or result in remedial and other costs, fines or lawsuits.
Risks Related to Our Capital Resources and Impairments
We will require additional financing and our failure to obtain additional funding would force us to delay, reduce or eliminate our product development programs or commercialization efforts.
We currently have limited committed sources of capital, and we have limited liquidity. Our cash and cash equivalents as of December 31, 2025 were $11.9 million. The Company previously maintained an Amended and Restated Equity Distribution Agreement (the “Prior ATM Agreement”) with Piper Sandler & Co. (“Piper Sandler”) and Clear Street, LLC (“Clear Street”), pursuant to which the Company could offer and sell shares of its common stock having an aggregate offering price of up to $17,111,650 from time to time through Piper Sandler and Clear Street, acting as sales agents, under a prospectus supplement dated October 18, 2024. As of December 31, 2025, the Company had sold 151,675 shares of common stock under the Prior ATM Agreement, resulting in net proceeds to the Company of approximately $1,660,805. The Prior ATM Agreement was subsequently terminated, and no further sales will be made under that program.
On October 20, 2025, the Company entered into a new Equity Distribution Agreement (the “Agreement”) with Maxim Group LLC (“Maxim”) to establish an at-the-market (“ATM”) equity offering program. Pursuant to the Agreement, the Company may offer and sell shares of its common stock, par value $0.001 per share, having an aggregate offering price of up to $10.0 million, from time to time through Maxim, acting as the Company’s sales agent. Under the terms of the Agreement, the Company will pay Maxim a commission equal to 3.0% of the gross proceeds from the sale of any shares and will reimburse Maxim for certain legal and other out-of-pocket expenses incurred in connection with its services. Sales of common stock, if any, may be made in transactions deemed to be “at-the-market” offerings as defined in Rule 415 under the Securities Act of 1933, as amended, including sales made by means of ordinary brokers’ transactions on The Nasdaq Capital Market or otherwise at market prices prevailing at the time of sale or at prices negotiated with Maxim. The Company is not obligated to sell any shares under the Agreement and may terminate the offering at any time in accordance with its terms. The shares will be issued pursuant to the Company’s shelf Registration Statement on Form S-3 (File No. 333-270628), which was declared effective by the Securities and Exchange Commission on April 6, 2023. On October 20, 2025, the Company filed a prospectus supplement with the SEC relating to the new ATM program, registering up to approximately $4.1 million of shares under the shelf registration statement. As of December 31, 2025, the Company had sold 31,667 shares of common stock under the Agreement, resulting in net proceeds to the Company of approximately $258,563.
If adequate funds to develop our product candidates and fund operations are not available on a timely basis, we may terminate or delay the development of one or more of our product candidates, or delay activities necessary to commercialize our product candidates. Additional funding may not be available to us on acceptable terms, or at all. Any additional equity financing, if available, may not be available on favorable terms and will most likely be dilutive to our current stockholders, and debt financing, if available, may involve more restrictive covenants. Our ability to access capital when needed is not assured and, if not achieved on a timely basis, will materially harm our business, financial condition and results of operations or could cause us to cease operations.
| 15 |
Our independent registered public accounting firm has included an explanatory paragraph relating to our ability to continue as a going concern in its report on our audited financial statements. We may be unable to continue to operate without the threat of liquidation for the foreseeable future.
Our report from our independent registered public accounting firm for the year ended December 31, 2025 includes an explanatory paragraph stating that our recurring losses from operations raises substantial doubt about our ability to continue as a going concern. If we are unable to obtain sufficient additional funding, our business, prospects, financial condition and results of operations will be materially and adversely affected, and we may be unable to continue as a going concern. If we are unable to continue as a going concern, we may have to liquidate our assets and may receive less than the value at which those assets are carried on our consolidated financial statements, and it is likely that investors will lose all or a part of their investment. Future reports from our independent registered public accounting firm may also contain statements expressing doubt about our ability to continue as a going concern. If we seek additional financing to fund our business activities in the future and there remains doubt about our ability to continue as a going concern, investors or other financing sources may be unwilling to provide additional funding on commercially reasonable terms or at all.
Raising additional capital by issuing securities or through debt financings or licensing arrangements will likely cause dilution to existing stockholders, restrict our operations or require us to relinquish proprietary rights.
To the extent that we raise additional capital through the sale of equity or convertible debt securities, your ownership interest will likely be diluted, and the terms may include liquidation or other preferences that adversely affect your rights as a stockholder. Debt financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions such as incurring additional debt, making capital expenditures or declaring dividends. If we raise additional funds through collaboration and licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies or products or grant licenses on terms that are not favorable to us. Any of these events could adversely affect our ability to achieve our product development and commercialization goals and have a material adverse effect on our business, financial condition and results of operations.
Risks Related to Regulatory Approval of Our Products and Other Government Regulations
We received Emergency Use Authorization or EUA for our Logix Smart COVID-19 test in the US. For our existing EUA and any new EUA, the FDA may revoke any EUA where it is determined that the underlying health emergency no longer exists or warrants such authorization, which would adversely impact our ability to market our COVID-19 test in the United States.
The FDA has the authority to grant an EUA to allow unapproved medical products to be used in an emergency to diagnose, treat or prevent serious or life-threatening diseases or conditions when there are no adequate, approved and available alternatives. During the COVID 19 pandemic the FDA determined that circumstances existed to justify the authorization of emergency use of medical devices, including alternative products used as medical devices, during the COVID-19 pandemic. On April 3, 2020, we received an EUA from the FDA for our Logix Smart Coronavirus Disease 2019 (COVID-19) kit for use on individuals who are suspected of COVID-19 by their healthcare provider. We cannot predict how long the EUA for our COVID-19 test will remain in place. The FDA may revoke an EUA where it is determined that the underlying health emergency no longer exists or warrants such authorization. The FDA may take such a position at any time and without notice and, therefore, we cannot predict how long our EUAs will remain in place. The FDA may also revoke an EUA when the circumstances justifying its issuance no longer exist, such as when an alternative is authorized for marketing through the standard procedures, including through a 510(k) clearance.
If our existing EUAs are revoked prior to us having received regulatory approval to commercialize our COVID-19 test through a traditional pathway, we may not be able to obtain required clearances or approvals in a timely manner, or at all, and one or more of our competitors may obtain the necessary clearances or approvals for their products before we do. In addition, we would be required to cease our commercialization efforts, which would substantially and negatively impact our business. As a result, any such revocation could adversely impact our business, financial condition and results of operations.
| 16 |
Our long-term success depends substantially on our ability to obtain regulatory clearance or approval and thereafter commercialize our product candidates; we cannot be certain that we will be able to do so in a timely manner or at all.
The process of obtaining regulatory clearances or approvals to market a medical diagnostic from the FDA or similar regulatory authorities outside of the United States can be costly and time consuming, and there can be no assurance that such clearances or approvals will be granted on a timely basis, or at all. The FDA’s 510(k) clearance process generally takes one to six months from the date of submission, depending on whether a special or traditional 510(k) premarket notification has been submitted, but can take significantly longer. An application for premarket approval, or PMA, must be submitted to the FDA if the device cannot be cleared through the 510(k) clearance process or is not exempt from premarket review by the FDA. The PMA process almost always requires one or more clinical trials and can take two to three years from the date of filing, or even longer.
If we are required to obtain approval of any of our products through the PMA process, the costs associated with such a process will be significant, which could adversely affect our financial performance and results of operations. In addition, a submission through the PMA process would require us to delay commercialization of such product candidates until after approval is received, if ever. If we are unable to commercialize our product candidates in a timely manner, or at all, our business will be adversely affected.
Similar to our compliance with U.S. regulatory requirements, we must obtain and comply with international requirements, in order to market and sell our products outside of the United States and we may only promote and market our products, if approved, as permitted by applicable regulatory authorities. There is no guarantee that we will receive the necessary regulatory approvals for our product candidates either inside the United States or internationally. If our product candidates do not receive necessary regulatory approvals, our business could be materially and adversely affected.
Our current and future relationships with third-party payers and current and potential customers in the United States and elsewhere may be subject, directly or indirectly, to applicable anti-kickback, fraud and abuse, false claims, transparency, health information privacy and security and other healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm administrative burdens and diminished profits and future earnings.
Our current and future arrangements with third-party payers and current and potential customers, including providers and physicians, may expose us to broadly applicable fraud and abuse and other healthcare laws and regulations, including, without limitation, the federal Anti-Kickback Statute and the federal False Claims Act, which may constrain the business or financial arrangements and relationships through which we sell, market and distribute our products. In addition, we may be subject to transparency laws and patient privacy regulations by U.S. federal and state governments and by governments in foreign jurisdictions in which we conduct our business. The applicable federal, state and foreign healthcare laws and regulations that may affect our ability to operate include:
| ● | the federal Anti-Kickback Statute, which prohibits, among other things, persons from knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward, or in return for, either the referral of an individual for, or the purchase, order or recommendation of, any good or service, for which payment may be made under federal healthcare programs, such as Medicare and Medicaid; | |
| ● | federal civil and criminal false claims laws and civil monetary penalty laws, including the federal False Claims Act, which impose criminal and civil penalties, including civil whistleblower or qui tam actions, against individuals or entities for knowingly presenting, or causing to be presented, to the federal government, including the Medicare and Medicaid programs, claims for payment that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government; | |
| ● | the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, which imposes criminal and civil liability for executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters; | |
| ● | HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, or HITECH, and their respective implementing regulations, which impose obligations on covered healthcare providers, health plans, and healthcare clearinghouses, as well as their business associates that create, receive, maintain or transmit individually identifiable health information for or on behalf of a covered entity, with respect to safeguarding the privacy, security and transmission of individually identifiable health information; | |
| ● | the Physician Payments Sunshine Act, which requires (i) manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program, with specific exceptions, to report annually to CMS information related to certain “payments or other transfers of value” made to physicians, which is defined to include doctors, dentists, optometrists, podiatrists and chiropractors, and teaching hospitals, (ii) applicable manufacturers and applicable group purchasing organizations to report annually to CMS ownership and investment interests held in such entities by physicians and their immediate family members, with data collection beginning on August 1, 2013, (iii) manufacturers to submit reports to CMS by the 90th day of each calendar year, and (iv) disclosure of such information by CMS on a publicly available website; and | |
| ● | analogous state and foreign laws and regulations, such as state anti-kickback and false claims laws, which may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third-party payers, including private insurers; state and foreign laws that require medical device companies to comply with the medical device industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government or otherwise restrict payments that may be made to healthcare providers; state and foreign laws that require medical device manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures; and state and foreign laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts. |
| 17 |
Efforts to ensure that our business arrangements with third parties will comply with applicable healthcare laws and regulations may involve substantial costs. It is possible that governmental authorities will conclude that our business practices may not comply with current or future statutes, regulations or case law involving applicable fraud and abuse or other healthcare laws and regulations. If our operations are found to be in violation of any of these laws or any other governmental regulations that may apply to us, we may be subject to significant civil, criminal and administrative penalties, including, without limitation, damages, fines, imprisonment, exclusion from participation in government healthcare programs, such as Medicare and Medicaid, and the curtailment or restructuring of our operations, which could have a material adverse effect on our business. If any of the physicians or other healthcare providers or entities with whom we expect to do business, including our collaborators, are found not to be in compliance with applicable laws, they may be subject to criminal, civil or administrative sanctions, including exclusions from participation in government healthcare programs, which could also materially affect our business.
We are subject to numerous and evolving data protection, privacy and information security laws in the jurisdictions in which we operate. These laws govern the collection, use, disclosure, transfer and safeguarding of personal information, including health-related information. The regulatory framework for data privacy and data security is rapidly evolving, and interpretation and enforcement practices remain uncertain. New or amended laws, or differing interpretations of existing laws, may require us to incur additional compliance costs, modify our business practices or restrict certain operations.
In the United States, we may be subject to the Health Insurance Portability and Accountability Act of 1996, as amended by HITECH (collectively, “HIPAA”), to the extent we act as a covered entity or business associate. HIPAA establishes privacy and security standards for the protection of protected health information and authorizes significant civil and criminal penalties for noncompliance. In addition, all 50 U.S. states and the District of Columbia have enacted breach notification laws, and many states have adopted broader privacy and data security requirements that may impose additional obligations and liabilities.
We may also be subject to international data protection laws, including those in the European Union and other jurisdictions, which impose stringent requirements on the processing and transfer of personal information and authorize significant fines for violations.
A failure or perceived failure by us, our employees, or our third-party service providers to comply with applicable data protection laws or to adequately safeguard personal information could result in regulatory investigations or enforcement actions, fines, litigation, contractual liability, mandatory notifications, reputational harm and loss of customer confidence. We rely on third-party vendors to process and store certain data, and any security breach or noncompliance by such vendors could adversely affect us, even if we are not directly at fault.
We maintain general liability and cyber insurance coverage; however, such coverage may not be adequate to cover all liabilities or may not be available on acceptable terms in the future. Any significant data security incident, regulatory proceeding or enforcement action could materially and adversely affect our business, financial condition and results of operations.
We are subject to evolving global data protection and privacy laws, and compliance with such laws may be costly and may expose us to liability.
We collect and process personal information in connection with our operations, including clinical research activities and interactions with healthcare providers. As a result, we may be subject to various U.S. federal and state laws governing the privacy and security of personal information, including, where applicable, the Health Insurance Portability and Accountability Act of 1996, as amended (“HIPAA”), state breach notification laws, and state consumer privacy laws such as the California Consumer Privacy Act, as amended by the California Consumer Rights Act. These laws impose requirements relating to the collection, use, disclosure and safeguarding of personal information and may provide for significant civil penalties and, in some cases, private rights of action.
We may also be subject to international data protection laws, including the European Union General Data Protection Regulation (“GDPR”) and the United Kingdom GDPR, which impose strict requirements regarding the processing and transfer of personal data and authorize substantial fines for non-compliance.
The data protection regulatory environment is rapidly evolving, and new or amended laws, differing interpretations, and increased enforcement activity may require us to incur additional compliance costs, implement new safeguards, or change our business practices. A failure or perceived failure to comply with applicable privacy and data protection laws, or any data security incident involving personal information, whether by us or our third-party service providers, could result in regulatory investigations, fines, litigation, contractual liability, reputational harm and loss of customer confidence, any of which could materially and adversely affect our business, financial condition and results of operations.
| 18 |
Risks Related to Our Intellectual Property
If the combination of patents, trade secrets and contractual provisions that we rely on to protect our intellectual property is inadequate, our ability to commercialize our products successfully will be harmed, and we may not be able to operate our business profitably.
Our success depends significantly on our ability to protect our proprietary rights to the technologies incorporated in our products. We rely on a combination of patent protection, trade secret laws and nondisclosure, confidentiality and other contractual restrictions to protect our proprietary technology. However, these may not adequately protect our rights or permit us to gain or keep any competitive advantage.
The issuance of a patent is not conclusive as to its scope, validity or enforceability. The scope, validity or enforceability of our issued patents can be challenged in litigation or proceedings before the U.S. Patent and Trademark Office, or the USPTO, or foreign patent offices. In addition, our pending patent applications include claims to numerous important aspects of our products under development that are not currently protected by any of our issued patents. We cannot assure you that any of our pending patent applications will result in the issuance of patents to us. The USPTO or foreign patent offices may deny or require significant narrowing of claims in our pending patent applications. Patents issued as a result of the pending patent applications, if any, may not provide us with significant commercial protection or be issued in a form that is advantageous to us. Proceedings before the USPTO or foreign patent offices could result in adverse decisions as to the priority of our inventions and the narrowing or invalidation of claims in issued patents. The laws of some foreign countries may not protect our intellectual property rights to the same extent as the laws of the United States, if at all.
Our competitors may successfully challenge and invalidate or render unenforceable our issued patents, including any patents that may issue in the future, which could prevent or limit our ability to market our products and could limit our ability to stop competitors from marketing products that are substantially equivalent to ours. In addition, competitors may be able to design around our patents or develop products that provide outcomes that are comparable to our products but that are not covered by our patents.
In the event a competitor infringes upon any of our patents or other intellectual property rights, enforcing our rights may be difficult, time-consuming and expensive, and would divert management’s attention from managing our business. There can be no assurance that we will be successful on the merits in any enforcement effort. In addition, we may not have sufficient resources to litigate, enforce or defend our intellectual property rights.
We could become subject to intellectual property litigation that could be costly, result in the diversion of management’s time and efforts, require us to pay damages, prevent us from marketing our commercially available products or product candidates and/or reduce the margins we may realize from our products that we may commercialize.
Whether a product infringes a patent involves complex legal and factual issues, and the determination is often uncertain. There may be existing patents of which we are unaware that our products under development may inadvertently infringe. The likelihood that patent infringement claims may be brought against us increases as the number of participants in the in vitro diagnostics market increases and as we achieve more visibility in the marketplace and introduce products to market.
Any infringement claim against us, even if without merit, may cause us to incur substantial costs, and would place a significant strain on our financial resources, divert the attention of management from our core business, and harm our reputation. In some cases, litigation may be threatened or brought by a patent holding company or other adverse patent owner who has no relevant product revenues and against whom our patents may provide little or no deterrence. If we were found to infringe any patents, we could be required to pay substantial damages, including triple damages if an infringement is found to be willful, and royalties and could be prevented from selling our products unless we obtain a license or are able to redesign our products to avoid infringement. We may not be able to obtain a license enabling us to sell our products on reasonable terms, or at all, and there can be no assurance that we would be able to redesign our products in a way that would not infringe those patents. If we fail to obtain any required licenses or make any necessary changes to our technologies or the products that incorporate them, we may be unable to commercialize one or more of our products or may have to withdraw products from the market, all of which would have a material adverse effect on our business, financial condition and results of operations.
| 19 |
We rely substantially on our trademarks and trade names. If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be harmed.
We rely substantially upon trademarks to build and maintain the integrity of our brand. Our registered and unregistered trademarks or trade names may be challenged, infringed, circumvented, declared unenforceable or determined to be violating or infringing on other intellectual property rights. We may not be able to protect or enforce our rights to these trademarks and trade names, which we rely upon to build name recognition among potential partners and customers in our markets of interest. At times, competitors or other third parties may adopt trade names or trademarks similar to ours, thereby impeding our ability to build brand identity and possibly leading to market confusion. Asserting claims against such third parties may be prohibitively expensive. In addition, there could be potential trade name or trademark infringement, or dilution claims brought by owners of other trademarks against us. Over the long term, if we are unable to establish name recognition based on our trademarks and trade names, then we may not be able to compete effectively, and our business may be adversely affected. Our efforts to enforce or protect our proprietary rights related to trademarks, trade secrets, domain names or other intellectual property may be ineffective, could result in substantial costs and diversion of resources and could harm our business, financial condition and results of operations.
Risks Related to Litigation from Operating Our Business
Current or future litigation, government investigations and other legal proceedings may harm our business.
We have been, currently are and may in the future become, involved in legal proceedings that could have a negative impact on our reputation, business and financial condition and divert the attention of our management from the operation of our business. The types of legal proceedings we may be or become subject to include patent and other intellectual property claims, product liability claims, employee claims, tort or contract claims, federal or state regulatory investigations, securities class actions and shareholder derivative actions, and other legal proceedings, investigations or claims. For example, we are currently parties to two securities class action claims and three derivative actions. Litigation and other legal proceedings are inherently unpredictable and can result in excessive or unanticipated verdicts and/or injunctive relief that affect how we operate our business. We obtain business insurance, including executive and corporate securities liability insurance to insure against such claims should they arise. The insurance we have in place for such events may prove to be inadequate to pay a damage award, we may have to pay the excess of this award out of our cash reserves, which could significantly harm our financial condition. A legal proceeding claim, even one without merit, could harm our reputation in the industry, lead to significant legal fees, and result in the diversion of management’s attention from managing our business. We could incur judgments or enter into settlements of claims for monetary damages or for agreements to change the way we operate our business, or both. There may be an increase in the scope of these matters or there may be additional lawsuits, claims, proceedings or investigations in the future, which could harm our business, financial condition and results of operations. Adverse publicity about regulatory or legal action against us could damage our reputation and brand image, undermine our customers’ confidence and reduce long-term demand for any of our products or other offerings, even if the regulatory or legal action is unfounded or not material to our operations. For additional information, see “Item 3. Legal Proceedings.”
| 20 |
General Risk Factors
The price of our common stock may fluctuate substantially.
The market price of our common stock may be subject to wide fluctuation in response to various factors, some of which are beyond our control. Some factors that may cause the market price of our common stock to fluctuate, in addition to the other risks mentioned in this “Risk Factors” section and elsewhere in this report, are:
| ● | sales or purchases of our common stock by our shareholders, executives, and directors; | |
| ● | our ability to obtain regulatory approval to commercialize our PCR platform on a timely basis or at all; | |
| ● | our ability to enter new markets; | |
| ● | actual or unanticipated fluctuations in our annual and quarterly financial results; | |
| ● | our ability to obtain financings to continue and expand our commercial activities, expand our manufacturing operations, conduct research and development activities including, but not limited to, human clinical trials, and other business activities; | |
| ● | our ability to secure resources and the necessary personnel to continue and expand our commercial activities, develop additional diagnostic tests, conduct clinical trials and gain approval for our diagnostic tests on our desired schedule; | |
| ● | commencement, enrollment or results of our clinical trials of our diagnostic tests or any future clinical trials we may conduct; | |
| ● | changes in the development status of our diagnostic tests; | |
| ● | any delays or adverse developments or perceived adverse developments with respect to review by the FDA or other similar foreign regulatory authorities of our planned clinical trials; | |
| ● | any delay in our submission for studies or test approvals or adverse regulatory decisions, including failure to receive regulatory approval or clearance for our diagnostic tests; | |
| ● | our announcements or our competitors’ announcements regarding new tests, enhancements, significant contracts, acquisitions or strategic investments; | |
| ● | failures to meet external expectations or management guidance; | |
| ● | changes in our capital structure or dividend policy, including future issuances of securities and sales of large blocks of common stock by our shareholders; | |
| ● | announcements and events surrounding financing efforts, including debt and equity securities; | |
| ● | competition from existing technologies and diagnostic tests or new technologies and diagnostic tests that may emerge; | |
| ● | announcements of acquisitions, partnerships, collaborations, joint ventures, new diagnostic tests, capital commitments, or other events by us or our competitors; | |
| ● | changes in general economic, political and market conditions in any of the regions in which we conduct our business; | |
| ● | changes in industry conditions or perceptions; | |
| ● | changes in valuations of similar companies or groups of companies; | |
| ● | analyst research reports, recommendations and changes in recommendations, price targets and withdrawals of coverage; | |
| ● | departures and additions of key personnel; | |
| ● | disputes and litigations related to intellectual properties, proprietary rights, and contractual obligations; | |
| ● | changes in applicable laws, rules, regulations, or accounting practices and other dynamics; | |
| ● | other events or factors, many of which may be out of our control. |
In addition, if the market for stocks in our industry or industries related to our industry, or the stock market in general, experiences a loss of investor confidence, the trading price of our common stock could decline for reasons unrelated to our business, financial condition and results of operations. If any of the foregoing occurs, it could cause our stock price to fall and may expose us to lawsuits that, even if unsuccessful, could be costly to defend and a distraction to management.
| 21 |
Anti-takeover provisions in our charter documents and Utah law could discourage, delay, or prevent a change of control of our Company and may affect the trading price of our common stock.
We are a Utah corporation and the anti-takeover provisions of the Utah Control Shares Acquisition Act may discourage, delay or prevent a change of control by limiting the voting rights of control shares acquired in a control share acquisition. In addition, our Articles of Incorporation and Bylaws may discourage, delay or prevent a change in our management or control over us that shareholders may consider favorable. Among other things, our Amended and Restated Articles of Incorporation and Bylaws:
| ● | authorize the issuance of “blank check” preferred stock that could be issued by our board of directors in response to a takeover attempt; | |
| ● | provide that vacancies on our board of directors, including newly created directorships, may be filled only by a majority vote of directors then in office, except a vacancy occurring by reason of the removal of a director without cause shall be filled by vote of the shareholders; | |
| ● | no right to cumulative voting; | |
| ● | limit who may call special meetings of shareholders |
These provisions could have the effect of delaying or preventing a change of control, whether or not it is desired by, or beneficial to, our shareholders.
We do not currently intend to pay dividends on our common stock.
We do not expect to pay cash dividends on our common stock. Any future dividend payments are within the absolute discretion of our board of directors and will depend on, among other things, our results of operations, working capital requirements, capital expenditure requirements, financial condition, contractual restrictions, business opportunities, anticipated cash needs, provisions of applicable law and other factors that our board of directors may deem relevant. We may not generate sufficient cash from operations in the future to pay dividends on our common stock.
We are a “smaller reporting company” and the reduced disclosure requirements applicable to smaller reporting companies may make our common stock less attractive to investors.
We are currently a “smaller reporting company” as defined in the Securities Exchange Act of 1934. Smaller reporting companies are able to provide simplified executive compensation disclosures in their filings, and have certain other decreased disclosure obligations in their SEC filings, including, among other things, only being required to provide two years of audited financial statements in annual reports. We cannot predict whether investors will find our common stock less attractive because of our reliance on any of these exemptions. If some investors find our common stock less attractive as a result, there may be a less active trading market for our common stock and our stock price may be more volatile.
We incur substantial costs as a result of being a public company and our management expects to devote substantial time to public company compliance programs.
As a public company, we incur significant legal, insurance, accounting and other expenses, including costs associated with public company reporting. We intend to invest resources to comply with evolving laws, regulations and standards, and this investment will result in increased general and administrative expenses and may divert management’s time and attention from product development and commercialization activities. If our efforts to comply with new laws, regulations and standards differ from the activities intended by regulatory or governing bodies due to ambiguities related to practice, regulatory authorities may initiate legal proceedings against us, and our business may be harmed. These laws and regulations could make it more difficult and costlier for us to obtain director and officer liability insurance for our directors and officers, and we may be required to accept reduced coverage or incur substantially higher costs to obtain coverage. These factors could also make it more difficult for us to attract and retain qualified executive officers and qualified members of our board of directors, particularly to serve on our audit and compensation committees. In addition, if we are unable to continue to meet the legal, regulatory and other requirements related to being a public company, we may not be able to maintain the listing of our common stock on The NASDAQ Capital Market, which would likely have a material adverse effect on the trading price of our common stock.
| 22 |
We incur substantial costs as a result of being a public company and are subject to the continued listing requirements of the NASDAQ Capital Market, our management expects to devote substantial time to public company compliance programs.
As a public company, we incur significant legal, insurance, accounting and other expenses, including costs associated with public company reporting. We intend to invest resources to comply with evolving laws, regulations and standards, and this investment will result in increased general and administrative expenses and may divert management’s time and attention from product development and commercialization activities. If our efforts to comply with new laws, regulations and standards differ from the activities intended by regulatory or governing bodies due to ambiguities related to practice, regulatory authorities may initiate legal proceedings against us, and our business may be harmed. These laws and regulations could make it more difficult and costlier for us to obtain director and officer liability insurance for our directors and officers, and we may be required to accept reduced coverage or incur substantially higher costs to obtain coverage. These factors could also make it more difficult for us to attract and retain qualified executive officers and qualified members of our board of directors, particularly to serve on our audit and compensation committees. In addition, if we are unable to continue to meet the legal, regulatory and other requirements related to being a public company, we may not be able to maintain the listing of our common stock on The NASDAQ Capital Market, which would likely have a material adverse effect on the trading price of our common stock.
Currently our common stock is quoted on the NASDAQ Capital Market under the symbol “CODX”. We must satisfy certain minimum listing maintenance requirements to maintain the NASDAQ Capital Market quotation, including certain governance requirements and a series of financial tests relating to stockholders’ equity or net income or market value, public float, number of market makers and stockholders, market capitalization, and maintaining a minimum bid price of $1.00 per share.
As previously disclosed, on January 10, 2025, the Company received a notice from the Listing Qualifications Department of The NASDAQ Stock Market (the “Staff”) stating that the bid price of the Company’s common stock for the previous 30 consecutive trading days had closed below the minimum $1.00 per share required for continued listing on The NASDAQ Capital Market under NASDAQ Listing Rule 5550(a)(2). The Company had an initial period of 180 calendar days to regain compliance with Listing Rule 5550(a)(2). To regain compliance, the bid price of the Company’s common stock must close at $1 or more for a minimum of ten consecutive business days before July 9, 2025.
On July 10, 2025, the Company received notification from the Staff indicating that the Company would have an additional 180-day grace period, until January 5, 2026, to regain compliance with NASDAQ’s $1.00 minimum bid requirement. The notification indicated that the Company did not regain compliance during the initial 180-day grace period provided under the rule. In accordance with NASDAQ Marketplace Rule 5810(c)(3)(A), the Company was eligible for the additional grace period because it met the continued listing requirement for market value of publicly held shares and all other applicable requirements for initial listing on the Nasdaq Capital Market with the exception of the bid price requirement, and provided written notice of its intention to cure the deficiency during the second compliance period by effecting a reverse stock split, if necessary.
In order to regain compliance with the $1.00 minimum bid price requirement, on January 1, 2026 we effected a 1-for-30 reverse stock split (the “Reverse Stock Split”). The Reverse Stock Split reduced the number of shares of common stock outstanding from approximately 62.9 million shares to approximately 2.1 million shares. On January 7, 2026, the Company received written notice from the Staff indicating that the Staff had determined to delist the Company’s common stock from The Nasdaq Capital Market due to the Company’s continued non-compliance with the minimum bid price requirement set forth in Nasdaq Listing Rule 5550(a)(2). The Company subsequently requested a hearing before the Nasdaq Hearings Panel to address the bid price deficiency; however, the Company’s securities were suspended from trading on The Nasdaq Capital Market effective at the open of trading on January 14, 2026, in accordance with Nasdaq Listing Rule 5815(a)(1)(B)(ii)(d).
On February 12, 2026, the Company participated in a hearing with the Nasdaq Hearings Panel. On March 9, 2026, the Company was formally notified by Nasdaq that it had demonstrated compliance with the $1.00 bid price requirement set forth in Nasdaq Listing Rule 5550(a)(2) and all other applicable criteria for continued listing on The Nasdaq Capital Market. Accordingly, the Company’s securities resumed trading on Nasdaq effective with the open of the market on March 11, 2026, and the previously disclosed listing matter before the Nasdaq Hearing Panel was closed.
The Nasdaq Hearings Panel imposed a Discretionary Panel Monitor for a period of one year, through March 9, 2027. If, during the monitoring period, the Company’s closing bid price falls below $1.00 per share for 30 consecutive business days, the Company will not be eligible for a 180-day compliance period otherwise available under the Nasdaq Listing Rules. Rather, Nasdaq would issue a delist determination, which the Company could then appeal by requesting a hearing before the Panel. Such request would stay any further action by Nasdaq pending the conclusion of the hearing process. Although we have regained compliance with Nasdaq’s continued listing requirements, there can be no assurance that we will maintain compliance with all applicable listing standards in the future.
ITEM 1B. UNRESOLVED STAFF COMMENTS
None.
| 23 |
ITEM 1C. CYBERSECURITY
To manage our material risks from cybersecurity threats and to protect against, detect, and prepare to respond to cybersecurity incidents, we undertake the below listed activities:
| ● | Monitor evolving cybersecurity standards and emerging data protection laws and implement changes to our processes to comply; | |
| ● | risk assessments designed to help identify material cybersecurity risks to our critical systems, information, products, services, and our broader enterprise IT environment; | |
| ● | The Company leverages third-party vendors to house critical clinical trial data. These vendors are required to be GxP compliant which entails strong cybersecurity controls that are validated by a third-party auditor. Furthermore, the Company has begun performing security risk assessments prior to on-boarding new significant vendors. | |
| ● | The Company provides regular, mandatory training for all levels of employees regarding cybersecurity threats as a means to equip the Company’s employees with effective tools to address cybersecurity threats, and to communicate the Company’s evolving information security policies, standards, processes, and practices. | |
| ● | Employ multifactor authentication on internal and external systems; | |
| ● | Conduct regular phishing email simulations for all employees; and | |
| ● | Carry cybersecurity risk insurance that provides protection against the potential losses arising from a cybersecurity incident. |
Our incident response plan coordinates the activities that we and our third-party cybersecurity providers take to prepare to respond and recover from cybersecurity incidents, which include processes to triage, assess severity, investigate, escalate, contain, and remediate an incident, as well as to comply with potentially applicable legal obligations and mitigate brand and reputational damage.
As
part of the above processes,
Our processes also include assessing cybersecurity threat risks associated with our use of third-party services providers in normal course of business use, including those in our supply chain or who have access to patient and employee data or our systems. Third-party risks are included within our risk management process discussed above. In addition, we assess cybersecurity considerations in the selection and oversight of our third-party services providers, including due diligence on the third parties that have access to our systems and facilities that house systems and data.
To date, we have not experienced any material internal or external cybersecurity incidents, and we do not believe that there are currently any known risks from cybersecurity threats that are reasonably likely to materially affect our business strategy, results of operations or financial condition. However, cybersecurity threats may affect our business. See “Cyber security risks and the failure to maintain the integrity of company, employee or guest data could expose us to data loss, litigation and liability, and our reputation could be significantly harmed.” in “Item 1A. Risk Factors” of this Annual Report on Form 10-K.
In addition, management maintains processes to identify, assess and manage cybersecurity risks associated with third-party service providers, including vendors that have access to our systems or data. These processes include risk-based due diligence, contractual protections, and ongoing monitoring, as appropriate, based on the nature of the services provided and the sensitivity of the information involved. Management is responsible for the day-to-day oversight of cybersecurity risk, including the evaluation of potential incidents and the implementation of our incident response procedures. Cybersecurity incidents are assessed by management based on severity, scope and potential impact, and are escalated to senior management and, where appropriate, to the Audit Committee. The Audit Committee is informed of material cybersecurity risks and incidents and provides updates to the full Board of Directors as part of its oversight responsibilities.
| 24 |
ITEM 2. PROPERTIES
Our headquarters are located at 2401 S. Foothill Drive, Salt Lake City, Utah. Our current facilities have approximately 50,000 square feet of laboratory, manufacturing, storage and office space under leases that expire in 2026 through 2028. We believe the facilities we lease are sufficient to meet our needs for the foreseeable future.
ITEM 3. LEGAL PROCEEDINGS
In the ordinary course of business, we are at times subject to various legal proceedings and disputes, including the proceedings specifically discussed below. We assess our liabilities and contingencies in connection with outstanding legal proceedings utilizing the latest information available. Where it is probable that we will incur a loss and the amount of the loss can be reasonably estimated, we record a liability in our consolidated financial statements. These legal reserves may be increased or decreased to reflect any relevant developments on a quarterly basis. Where a loss is not probable or the amount of loss is not estimable, we do not accrue legal reserves. While the outcome of legal proceedings is inherently uncertain, based on information currently available and available insurance coverage, our management believes that it has established appropriate legal reserves. Any incremental liabilities arising from pending legal proceedings are not expected to have a material adverse effect on our consolidated financial position, consolidated results of operations, or consolidated cash flows. However, it is possible that the ultimate resolution of these matters, if unfavorable, may be material to our consolidated financial position, consolidated results of operations, or consolidated cash flows.
Class Actions and Shareholder Derivative Suits
Shareholder Derivative Lawsuits (District of Utah & Utah State Court)
On September 17, 2020, a shareholder derivative lawsuit was filed in the District of Utah by Luis Aguilera, allegedly on behalf of Co-Diagnostics, Inc. The Aguilera lawsuit asserted that the defendants failed to prevent alleged securities law violations. On December 2, 2020, a second similar shareholder derivative lawsuit was filed in the District of Utah by Melvyn Klein. On April 29, 2021, the District of Utah consolidated the Aguilera and Klein lawsuits, with the Aguilera case serving as the lead case under the caption In re Co-Diagnostics, Inc. Derivative Litigation. On November 24, 2020, an additional shareholder derivative lawsuit was filed in the District of Utah by Matthew Wallace, which named the same defendants and asserted essentially the same claims as in the Aguilera shareholder derivative action. On January 25, 2021, another similar shareholder derivative lawsuit was filed in the District of Utah by Jason Reagan. On March 18, 2021, the court consolidated the Wallace and Reagan lawsuits, with the Wallace lawsuit serving as the lead case. On March 29, 2021, an additional shareholder derivative lawsuit was filed in the Third District Court in and for Salt Lake County, State of Utah (“Utah State Court”) by Hua Ding. On December 12, 2022, a second similar shareholder derivative lawsuit was filed in Utah State Court by Kathryn Matuch. Each of the shareholder derivative lawsuits mentioned here was voluntarily dismissed without prejudice.
| 25 |
Stadium Capital Securities Class Action (Southern District of New York)
On August 16, 2022, Stadium Capital LLC (“Stadium”) filed a lawsuit in the United States District Court for the Southern District of New York, against Co-Diagnostics, Inc., and certain of our officers, on behalf of itself and a putative class, seeking to recover damages for alleged violations of Sections 10(b) and 20(a) of the Securities Exchange Act of 1934. The complaint alleges that Co-Diagnostics and the individual defendants overstated the demand for the Company’s Logix Smart COVID-19 test in statements on May 12, 2022 and June 15, 2022, and that plaintiff suffered losses when the Company’s stock price dropped after the Company disclosed its financial results for the quarter ended June 30, 2022 in a press release on August 11, 2022. On September 19, 2022, a second plaintiff, Drew Lee, filed a similar complaint in the same court against the same defendants alleging essentially the same claims. On August 9, 2023, the court consolidated these two securities class actions into the Stadium action and appointed Stadium as lead plaintiff. On September 21, 2023, Stadium filed a consolidated amended complaint, and on October 20, 2023, defendants moved to dismiss. On February 5, 2024, the Court granted in part and denied in part the defendants’ motion to dismiss, and on April 19, 2024, the Court dismissed an additional claim. Discovery on the remaining claims closed on February 7, 2025, and the parties filed cross-motions for summary judgment on March 21, 2025. On January 14, 2026, the Court granted in part and denied in part plaintiffs’ partial motion for summary judgment and denied the defendants’ motion for summary judgment. The case has now been set for trial in the Southern District of New York on October 5, 2026. The defendants believe the claims are without merit and intend to defend vigorously against them, but there can be no assurances as to the outcome.
Commercial Litigation
Co-Diagnostics, Inc. v. Hukui Technology, Inc., et al. (Third Judicial District Court, Salt Lake County, Utah)
The Company initiated this action in April 2021 seeking a declaratory judgment that it had no payment obligations to the defendants in connection with certain commercial arrangements. Defendants asserted counterclaims, including breach of contract, promissory estoppel, unjust enrichment and related claims, seeking damages of approximately $2.3 million.
In November 2023, the trial court granted summary judgment in favor of the Company and dismissed all counterclaims. On appeal, the Utah Court of Appeals affirmed in part and reversed in part, reinstating certain claims. A bench trial on the remaining claims was held in February 2026.
On March 25, 2026, the trial court issued its Findings of Fact, Conclusions of Law, and Ruling, finding in favor of the Company on its declaratory judgment claim and on all remaining counterclaims asserted by the defendants. The court concluded, among other things, that the Company did not breach any agreement with the defendants and that the defendants were not entitled to any damages.
While the Company believes the matter has been favorably resolved at the trial court level, the defendants may have the right to appeal the ruling. The Company intends to continue to vigorously defend its position in the event of any further proceedings.
Co-Diagnostics, Inc. v. Pantheon International Advisors Ltd. (Utah State Court)
In May 2021, the Company filed a declaratory judgment action in Utah seeking confirmation that it had no contractual relationship or payment obligations to Pantheon. The Company obtained a final default judgment in its favor in November 2021. Pantheon subsequently initiated proceedings in the United Kingdom asserting claims of approximately $2.9 million. On March 31, 2026, the parties entered into a settlement agreement to fully resolve all disputes, without any admission of liability. Under the agreement, the Company agreed to pay $140,000, and the parties agreed to dismiss the UK proceedings with prejudice and exchange mutual releases. The Company does not expect any further material loss related to this matter.
Robert Salna v. Co-Diagnostics, Inc., et al. (Third Judicial District Court, Salt Lake County, Utah)
In February 2024, the plaintiff filed suit against the Company and certain officers in connection with a 2018 loan transaction, alleging entitlement to equity-based compensation. The complaint asserts various claims, including breach of contract, fraud, and violations of federal and state securities laws, and seeks damages of not less than $10 million.
In 2025, a non-binding arbitration resulted in a decision in favor of the Company on all claims. The plaintiff has continued to pursue the litigation. The Company has filed a motion to dismiss, which is fully briefed, and a hearing is scheduled for May 2026. The Company believes the claims are without merit and intends to defend the action vigorously.
ITEM 4. MINE SAFETY DISCLOSURES
Not applicable.
| 26 |
PART II
ITEM 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER EQUITY SECURITIES
Market Information
Our common stock has been quoted on the NASDAQ market under the symbol “CODX” since July 12, 2017.
Holders
As of March 29, 2026, the last reported sales price reported on NASDAQ for our common stock was $1.75 per share. As of March 29, 2026, we had approximately 154 record holders of our common stock. The number of record holders was determined from the records of our transfer agent and does not include beneficial owners of common stock whose shares are held in the names of various security brokers, dealers, and registered clearing agencies. The transfer agent for our common stock is VStock Transfer LLC located at 18 Lafayette Pl, Woodmere, New York 11598.
Dividends
We have never declared or paid any cash dividends on our capital stock. The payment of dividends on our common stock in the future will depend on our earnings, capital requirements, operating and financial condition and such other factors as our board of directors may consider appropriate. We currently expect to use all available funds to finance the future development and expansion of our business and do not anticipate paying dividends on our common stock in the foreseeable future.
Pursuant to Section 16-10a-640 of the Utah Revised Business Corporation Act, no distribution may be made if, after giving it effect:
| (a) | the corporation would not be able to pay its debts as they become due in the usual course of business; or | |
| (b) | the corporation’s total assets would be less than the sum of its total liabilities plus, unless the articles of incorporation permit otherwise, the amount that would be needed, if the corporation were to be dissolved at the time of the distribution, to satisfy the preferential rights upon dissolution of shareholders whose preferential rights are superior to those receiving the distribution. |
Securities authorized for issuance under equity compensation plans
Information about our equity compensation plans in Item 12 of Part III of this Annual Report on Form 10-K is incorporated herein by reference.
Recent Sales of Unregistered Securities
None.
| 27 |
ITEM 6. RESERVED
ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULT OF OPERATIONS
The following management’s discussion and analysis of financial condition and results of operations describes the principal factors affecting the results of our operations, financial condition, and changes in financial condition. This discussion should be read in conjunction with the accompanying audited financial statements, and notes thereto, included elsewhere in this report. In addition to historical information, this Annual Report contains forward-looking statements that involve risks, uncertainties, and assumptions. Our actual results may differ materially from those anticipated in these forward-looking statements as a result of certain factors, including but not limited to those set forth under the caption “Item 1A. Risk Factors” in this Annual Report on Form 10-K.
Business Overview
Co-Diagnostics, Inc., a Utah corporation (the “Company” or “CODX”), develops, manufactures and sells reagents used for diagnostic tests that function via the detection and/or analysis of nucleic acid molecules (DNA or RNA), including molecular tools for detection of infectious diseases. Our diagnostics systems enable dependable, low-cost, molecular testing for organisms and genetic diseases by automating or simplifying historically complex procedures in both the development and administration of tests. CODX’s technical advance involves a novel, proprietary approach to polymerase chain reaction (“PCR”) test design of primer and probe structure (“Co-Primers®”) that dramatically reduces one of the key vexing issues of PCR amplification: the exponential growth of primer-dimer amplification (false positives) which adversely interferes with identification of the target DNA/RNA. Using our proprietary test design system and reagents, we have designed and obtained regulatory approval to sell PCR diagnostic tests for the detection of COVID-19, influenza, tuberculosis, hepatitis B and C, human papillomavirus, malaria, chikungunya, dengue, and the Zika virus. These initial diagnostic tests are cleared for use in clinical labs only and not for point-of-care or at-home use.
We have developed a portable diagnostic device and test system designed for point-of-care and at-home use. The system is comprised of our PCR instrument that we refer to as the Co-Dx™ PCR Pro® instrument, our patent-pending diagnostic test cup system and a mobile application to be installed on the user’s mobile device. We refer to the system as the “Co-Dx™ PCR platform” which has been designed to bring affordable, reliable polymerase chain reaction (“PCR”) testing to patients in point-of-care and at-home settings. The Co-Dx PCR platform is subject to U.S. Food and Drug Administration (“FDA”) review and is not available for sale at the time of this filing. In June 2024, we completed our first FDA application for 510(k) clearance for the Co-Dx PCR Pro instrument, the Co-Dx PCR COVID-19 Test, and the Co-Dx PCR mobile app for over-the-counter (OTC) use. Following engagement with the FDA during the review process, the Company voluntarily withdrew the 510(k) submission after discussions regarding the analytical approach for detecting potential degradation of a test component over its intended shelf life. While the Company believes that the matter identified during the review process could have been addressed through additional development and clinical validation activities, management determined that the capital and time required to resubmit the COVID-19 test for 510(k) clearance would be more effectively deployed toward development and clinical validation of the Co-Dx PCR Flu A/B, COVID-19, RSV multiplex test (“ABCR”). Moving focus to this test allows the Company to incorporate more recent Co-Dx PCR platform developments into the design and test manufacturing process. Management believes that a multiplex test targeting influenza A/B, COVID-19, and RSV better aligns with current clinical demand for comprehensive upper respiratory infection testing in point-of-care settings. Accordingly, clinical performance studies for the ABCR test are currently underway. There is no guarantee that our Co-Dx PCR platform will receive the necessary regulatory approvals for commercialization, or that, if regulatory approval is received, we will be able to successfully commercialize this platform.
Technology
We believe our proprietary and patented molecular diagnostics technology is paving the way for innovation in disease detection and life sciences research through our enhanced detection of genetic material. For various reasons, including owning our own platform, we believe we will be able to accomplish this faster and more economically than some competitors, allowing for significant margins while still positioning ourselves as a low-cost provider of molecular diagnostics and screening services. For example, we were the first US-based company to receive a CE-marking for a COVID-19 test in early 2020, as we worked to help slow the spread of the pandemic through our global network of distributors covering clinical labs in more than 50 countries. Our Logix Smart® COVID-19 test was designed, developed, submitted for regulatory approval and ready to be used as an in vitro diagnostic (“IVD”) in countries that accept CE marking for regulatory clearance in a period of just over 30 days. This is a real-world example of how CODX technology can be used in an evolving epidemic or pandemic to get diagnostic tools in the hands of medical professionals in a timely manner. It can be similarly used to design a test for mutated strains of SARS-CoV-2 or other viruses should they not be detectable using currently available tests.
In addition, continued development has demonstrated the unique properties of our Co-Primers technology that we believe makes it ideally suited for a variety of applications where specificity is key to optimal results, including multiplexing several targets, enhanced Single Nucleotide Polymorphism (“SNP”) detection and enrichment for next generation sequencing.
Our scientists use the complex mathematics of DNA/RNA PCR test design to engineer and optimize PCR tests and to automate algorithms that rapidly screen millions of possible options to pinpoint the optimum design. The intellectual property we use in our business consists of the predictive mathematical algorithms and patented molecular structure used in the testing process, which together represent a major advance in PCR testing systems. CODX technologies are now protected by more than 20 granted or pending US and foreign patents, as well as certain trade secrets and copyrights. Ownership of our proprietary platform permits us the advantage of avoiding payment of patent royalties required by other PCR test systems, which may allow for the sale of diagnostic PCR tests at a lower price than competitors, while enabling us to maintain profit margins.
| 28 |
Our proprietary test design process involves identifying the optimal locations on the target genes for amplification and pairing the locations with the optimized primer and probe structure to achieve outputs that meet the design input requirements identified from market research. This is done by following planned and documented processes, procedures and testing. In other words, we use the data resulting from our tests to verify whether we succeeded in designing what we intended. Verification involves a series of testing that concludes that the product is ready to proceed to validation in an evaluation either in our laboratory or in an independent laboratory setting using initial production tests to confirm that the product as designed meets the user’s needs.
Using our proprietary test design system and reagents, we have designed and obtained regulatory clearance in the European Community and in India (along with our joint venture, CoSara) to sell PCR diagnostic tests for the detection of COVID-19, influenza, tuberculosis, hepatitis B and C, human papillomavirus, malaria, chikungunya, dengue, and the Zika virus. In the United States, we obtained Emergency Use Authorization (“EUA”) for our Logix Smart® COVID-19 detection test from the FDA, and we sell that test to qualified labs. In addition, our COVID-19 detection test and certain of our other suite of COVID-19 products have been cleared for sale in countries such as the United Kingdom, Australia, India, and Mexico by the regulatory bodies in those countries and have been registered for sale in many more countries. In connection with the sale of our tests we may sell diagnostic equipment from other manufacturers, including an OEM’s PCR instrument which we refer to here as the “Co-Dx Box™”.
In addition to testing for infectious diseases, Co-Primers technology lends itself to identifying any section of a DNA or RNA strand that describes any type of genetic trait, which creates several significant applications. We, in conjunction with our customers, have designed tests that identify genetic traits in plant and animal genomes. We also have commercialized three multiplexed tests to test mosquitos for the presence of diseases they carry, which enables municipalities to concentrate their efforts in managing mosquito populations in specific areas where mosquitos carrying deadly viruses are known to breed.
RESULTS OF OPERATIONS
Results of Operations for the Years Ended December 31, 2025 and 2024
The table below provides a comparison of our operating results for the year ended December 31, 2025 as compared to the year ended December 31, 2024.
| Years Ended December 31, | Year Change | |||||||||||||||
| 2025 | 2024 | Change | % | |||||||||||||
| Product revenue | $ | 418,205 | $ | 770,048 | $ | (351,843 | ) | -46 | % | |||||||
| Grant revenue | 204,284 | 3,145,112 | (2,940,828 | ) | -94 | % | ||||||||||
| Total revenue | 622,489 | 3,915,160 | (3,292,671 | ) | -84 | % | ||||||||||
| Cost of revenue | 222,377 | 999,124 | (776,747 | ) | -78 | % | ||||||||||
| Gross profit | 400,112 | 2,916,036 | (2,515,924 | ) | -86 | % | ||||||||||
| Operating expenses | ||||||||||||||||
| Sales and marketing | 2,381,131 | 4,483,339 | (2,102,208 | ) | -47 | % | ||||||||||
| General and administrative | 9,058,283 | 16,157,152 | (7,098,869 | ) | -44 | % | ||||||||||
| Research and development | 19,137,242 | 20,979,589 | (1,842,347 | ) | -9 | % | ||||||||||
| Depreciation and amortization | 1,106,808 | 1,377,266 | (270,458 | ) | -20 | % | ||||||||||
| Impairment charges | 18,882,000 | - | 18,882,000 | - | ||||||||||||
| Total operating expenses | 50,565,464 | 42,997,346 | 7,568,118 | 18 | % | |||||||||||
| Loss from operations | (50,165,352 | ) | (40,081,310 | ) | (10,084,042 | ) | 25 | % | ||||||||
| Other income | ||||||||||||||||
| Interest income, net | 292,932 | 1,091,825 | (798,893 | ) | -73 | % | ||||||||||
| Realized gain on investments | 683,365 | 870,745 | (187,380 | ) | -22 | % | ||||||||||
| Gain (loss) on disposition of assets | (82,421 | ) | 8,291 | (90,712 | ) | -1094 | % | |||||||||
| Gain on remeasurement of acquisition contingencies | 805,863 | 714,876 | 90,987 | 13 | % | |||||||||||
| Loss on equity method investment in joint venture | (46,301 | ) | (186,067 | ) | 139,766 | -75 | % | |||||||||
| Total other income, net | 1,653,438 | 2,499,670 | (846,232 | ) | -34 | % | ||||||||||
| Loss before income taxes | (48,511,914 | ) | (37,581,640 | ) | (10,930,274 | ) | 29 | % | ||||||||
| Income tax provision (benefit) | (1,615,978 | ) | 57,368 | (1,673,346 | ) | -2917 | % | |||||||||
| Net loss | $ | (46,895,936 | ) | $ | (37,639,008 | ) | $ | (9,256,928 | ) | 25 | % | |||||
| 29 |
Revenues
For the year ended December 31, 2025, we generated $0.6 million of revenue compared to revenue of $3.9 million in the year ended December 31, 2024. The decrease in revenue of $3.3 million was primarily due to lower grant revenues, as the majority of revenue for grants previously awarded was recognized in the prior year.
Cost of Revenues and Gross Profit
Cost of revenues decreased by $0.8 million from $1.0 million for the year ended December 31, 2024 to $0.2 million for the year ended December 31, 2025. Included within cost of revenues is a decrease of approximately $0.1 million for the year ended December 31, 2025, and a decrease of approximately $0.1 million for the year ended December 31, 2024, related to reserves against certain raw materials and finished goods inventories. The initial recording of the reserves for obsolete inventory in the prior year, partially offset by the decrease in revenues in the current year, resulted in a higher gross margin percentage.
Operating Expenses
Total operating expenses were $50.6 million for the year ended December 31, 2025, compared to total operating expenses of $43.0 million for the year ended December 31, 2024. The increase in operating expenses was primarily due to the impairment charge recognized for in-process research and development intangible assets, partially offset by decreased legal expenses, stock-based compensation expense, and personnel related expenses.
Sales and marketing expenses for the year ended December 31, 2025, were $2.4 million compared to $4.5 million for the year ended December 31, 2024. The decrease of $2.1 million primarily a result of decreased stock-based compensation expense, tradeshow and travel expenses, consulting and professional services expenses, and personnel related expenses.
General and administrative expenses for the year ended December 31, 2025, were $9.1 million compared to $16.2 million for the year ended December 31, 2024. The decrease of $7.1 million was primarily due to decreases in legal expense, stock-based compensation expense and consulting and professional services expense, partially offset by increased expenses related to transaction advisory services and fees.
Research and development expenses for the year ended December 31, 2025, were $19.1 million compared to $21.0 million for the year ended December 31, 2024. The decrease of $1.8 million was primarily a result of decreased expenses related to development of the Co-Dx PCR platform, personnel related expenses, and stock-based compensation expense, partially offset by increases in expenses related to clinical trials for the Co-Dx PCR platform and professional services expense.
During the year ended December 31, 2025, the Company recognized impairment charges of $18.9 million related to in-process research and development intangible assets recorded in conjunction with the acquisitions of Idaho Molecular, Inc. and Advanced Conceptions, Inc. in 2021.
Other Income
Other income was $1.7 million for the year ended December 31, 2025, compared to other income of $2.5 million for the year ended December 31, 2024. The decrease in other income of $0.8 million was primarily due to decreases in interest income and realized gains from investments in marketable securities.
| 30 |
Net Loss
We realized a net loss for the year ended December 31, 2025 of $46.9 million compared to $37.6 million for the year ended December 31, 2024. The larger net loss of $9.3 million was primarily the result of the recognition of intangible asset impairment charges and decreases in grant revenues, partially offset by decreases in operating expenses. Additionally, we recorded an income tax benefit of $1.6 million during the year ended December 31, 2025, compared to an income tax expense of $0.1 million for the year ended December 31, 2024. The current year income tax benefit relates primarily to new United States tax legislation which was signed into law during 2025 which resulted in the Company being eligible for certain federal and state tax refunds related to prior years.
LIQUIDITY AND CAPITAL RESOURCES
At December 31, 2025, we had cash and cash equivalents of $11.9 million. Additionally, our total current assets at December 31, 2025, were $13.7 million compared to total current liabilities of $3.5 million.
Net cash used in operating activities during the year ended December 31, 2025 was $29.1 million, compared to net cash used in operating activities of $29.2 million for the year ended December 31, 2024. The slight decrease in cash used in operating activities was primarily due to lower operating expenses, primarily legal expenses, offset by decreases in grant revenue, net interest income, and realized gains on investments.
Net cash provided by investing activities was $26.3 million for the year ended December 31, 2025, compared to net cash provided by investing activities of $17.1 million during the year ended December 31, 2024. The increase in cash provided by investing activities is primarily due to the timing of the redemption of certain investments as they matured.
Net cash provided by financing activities was $11.8 million for the year ended December 31, 2025, compared to $0.1 million of cash provided by financing activities for the year ended December 31, 2024. The cash provided by financing activities during 2025 relates to issuances of common stock under the ATM and through registered direct offerings.
Since commencing sales of our Logix Smart COVID-19 test in March 2020, we have used our cash generated from those sales to fund the purchase of inventories and the development of our Co-Dx PCR Platform, and to pay our operating expenses.
Our available capital resources may be consumed more rapidly than currently expected and we may need or want to raise additional financing for strategic opportunities. It is anticipated that the Company will continue to generate operating losses and use cash in operations in the near term. If needed, we expect additional investment capital to come from additional issuances of our common stock or other equity-based securities with existing and new investors similar to those that have provided funding in the past or debt financing.
In September 2025, the Company completed a registered direct offering of 320,634 shares of its common stock to two institutional investors at an offering price of $12.00 per share, resulting in gross proceeds of approximately $3.8 million before deducting placement agent fees and other offering expenses. The shares were offered and sold pursuant to the Company’s effective shelf Registration Statement on Form S-3 (File No. 333-270628). Maxim Group LLC acted as placement agent for the transaction. The Company intends to use the net proceeds from the offering for working capital and general corporate purposes. See Note 16 – Registered Direct Offerings to the consolidated financial statements for additional information regarding this transaction.
| 31 |
In October 2025, the Company terminated its Amended and Restated Equity Distribution Agreement with Piper Sandler & Co. and Clear Street, LLC, under which it had previously sold an aggregate of 151,675 shares of common stock for net proceeds of approximately $1.7 million. Concurrently, the Company entered into a new Equity Distribution Agreement with Maxim Group LLC to establish an at-the-market (“ATM”) equity offering program, under which the Company may offer and sell shares of its common stock having an aggregate offering price of up to $10.0 million from time to time. In October 2025, the Company filed a prospectus supplement with the SEC relating to the new ATM program, registering up to approximately $4.1 million of shares under the shelf registration statement. The Company expects that any proceeds from sales under the new ATM program, if utilized, would provide additional financial flexibility to support its working capital requirements and general corporate purposes. As of December 31, 2025, the Company had sold 31,667 shares of common stock under the Agreement, resulting in net proceeds to the Company of approximately $258,563. There can be no assurance as to the timing or amount of any further sales under the new ATM program. See Note 15 – At the Market Agreement to the consolidated financial statements for additional information regarding this transaction.
In October 2025 the Company completed a second registered direct offering of 400,076 shares of its common stock and 24,167 pre-funded common stock purchase warrants to two institutional investors at offering prices of $16.50 per share and $16.497 per pre-funded warrant, resulting in gross proceeds of approximately $7.0 million before deducting placement agent fees and other offering expenses. The shares were offered and sold pursuant to the Company’s effective shelf Registration Statement on Form S-3 (File No. 333-270628). Maxim Group LLC acted as placement agent for the transaction. The Company intends to use the net proceeds from the offering for working capital and general corporate purposes. See Note 16 – Registered Direct Offerings to the consolidated financial statements for additional information regarding this transaction.
On January 1, 2026, we effected a 1-for-30 reverse stock split. The Reverse Stock Split reduced the number of shares of common stock outstanding from approximately 62.9 million shares to approximately 2.1 million shares. Although this Reverse Stock Split allowed us to regain compliance with Nasdaq’s continued listing requirements, there can be no assurance that we will maintain compliance with all applicable listing standards in the future.
Although we are seeking to obtain additional equity and/or debt financing, such funding is not assured and may not be available to us on favorable or acceptable terms and may involve significant restrictive covenants. Any additional equity financing is also not assured and, if available to us, will most likely be dilutive to our current stockholders. If we are not able to obtain additional debt or equity financing on a timely basis, the impact on us will be material and adverse. These uncertainties create substantial doubt about our ability to continue as a going concern. The consolidated financial statements do not include any adjustments that might result from the outcome of these uncertainties.
CRITICAL ACCOUNTING POLICIES AND ESTIMATES
Our management’s discussion and analysis of our financial condition and results of operations is based on our consolidated financial statements, which have been prepared in accordance with United States generally accepted accounting principles (“GAAP”). The preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements, as well as the reported revenues and expenses incurred during the reporting periods. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances. Actual results may differ from these estimates under different assumptions or conditions. While our significant accounting policies are described in Item 8 of this Annual Report on Form 10-K, within Note 2 of our consolidated financial statements in the section titled “Summary of Significant Accounting Policies”, we believe that the accounting policies discussed below are critical to understanding our historical and future performance, as these policies relate to the more significant areas involving management’s judgments and estimates.
Accounts Receivable
Trade accounts receivable are recorded at the invoiced amount, net of any allowance. The Company maintains an allowance for doubtful accounts for amounts the Company does not expect to collect. In establishing the required allowance, management considers historical losses, current market condition, customers’ financial condition, the age of receivables, and current payment patterns. Account balances are written off against the allowance once the receivable is deemed uncollectible. If actual accounts receivable collections are less favorable than those projected by management at the time of the assessment, however, additional accounts receivable write-downs may be required, which could reduce our earnings.
| 32 |
Intangible Assets
The useful lives of intangible assets with definite lives are based on the expected number of years the asset will generate revenue or otherwise be used by us and the related amortization is based on the straight-line method. Goodwill, which has an indefinite life, is not amortized but instead is tested at least annually for impairment, or more frequently when events or changes in circumstances indicate that the asset might be impaired. Examples of such events or circumstances include:
| ● | the assets’ ability to continue to generate income from operations and positive cash flow in future periods; | |
| ● | any volatility or significant decline in our stock price and market capitalization compared to our net book value; | |
| ● | loss of legal ownership or title to an asset; | |
| ● | significant changes in our strategic business objectives and utilization of our assets; and | |
| ● | the impact of significant negative industry or economic trends. |
If a change were to occur in any of the above-mentioned factors or estimates, the likelihood of a material change in our reported results would increase.
During the fourth quarter of 2025, we identified impairment indicators for our in-process research and development intangible assets, primarily due to a significant and sustained decline in our stock price and market capitalization compared to the assets’ net book value. We remeasured the fair value of these assets and recognized non-cash impairment charges of $18.9 million. This amount is reflected as impairment charges in the consolidated statements of operations and comprehensive loss for 2025. We did not recognize any impairment charges during 2024.
Inventories
We periodically review inventory for both potential obsolescence and potential declines in anticipated selling prices. In this review, we make assumptions about the future demand for and market value of the inventory and based on these assumptions estimate the amount of any obsolete, unmarketable, slow moving or overvalued inventory. We write down the value of our inventories by an amount equal to the difference between the cost of the inventory and the net realizable value. If actual market conditions are less favorable than those projected by management at the time of the assessment, however, additional inventory write-downs may be required, which could reduce our earnings.
Income Taxes
Significant judgment is required in determining our provision for income taxes, current tax assets and liabilities, deferred tax assets and liabilities, and our future taxable income, both as a whole and in various tax jurisdictions, for purposes of assessing our ability to realize future benefit from our deferred tax assets. We recognize in the financial statements the impact of a tax position if that position is more likely than not to be sustained during an audit, including resolution of related appeals or litigation processes, if any. While we believe that we have appropriate support for the positions taken on our tax returns, we regularly assess the potential outcome of examinations by tax authorities in determining the adequacy of our provision for income taxes. See Note 12 to our Consolidated Financial Statements for more information on income taxes.
The foregoing estimates, expectations and forward-looking statements are subject to change as we make strategic operating decisions from time to time and as our revenue and expenses fluctuate from period to period.
ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Not required.
| 33 |
ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA.
CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2025 AND 2024
Table of Contents
| Report of Independent Registered Public Accounting Firms (PCAOB ID No. |
35 |
| Consolidated Balance Sheets | 36 |
| Consolidated Statements of Operations and Comprehensive Loss | 37 |
| Consolidated Statement of Changes in Stockholders’ Equity | 38 |
| Consolidated Statements of Cash Flows | 39 |
| Notes to Consolidated Financial Statements | 40 |
| 34 |
Report of Independent Registered Public Accounting Firm
To the Board of Directors and Stockholders
Co-Diagnostics, Inc.
Opinion on the Consolidated Financial Statements
Going Concern
The financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 1 to the financial statements, the Company has recurring losses from operations and negative operating cash flows and needs to obtain additional financing to finance its operations. These issues raise substantial doubt about its ability to continue as a going concern. Management’s plans in regard to these matters are also described in Note 1. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Basis for Opinion
These consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s consolidated financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audits to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits, we are required to obtain an understanding of internal control over financial reporting, but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements. We believe that our audits provide a reasonable basis for our opinion.
Critical Audit Matters
The critical audit matter communicated below is a matter arising from the current period audit of the consolidated financial statements that was communicated or required to be communicated to the audit committee and that: (1) relates to accounts or disclosures that are material to the consolidated financial statements and (2) involved our especially challenging, subjective, or complex judgments. The communication of the critical audit matter does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing separate opinion on the critical audit matter or on the accounts or disclosures to which it relates.
Impairment of Intangible Assets
In December 2021 the Company acquired in-process research and development indefinite-lived intangible assets totaling $26,101,000. The Company assesses these assets for impairment at least annually or whenever events or changes in circumstances occur that may indicate impairment. The Company’s analysis for the year ended December 31, 2025, required significant judgement to assess qualitative factors in determining whether it is more likely than not that the indefinite-lived intangible assets are impaired. As a result of their analysis, the Company determined there was a $18,882,000 impairment on the intangible assets. As such, the Company wrote down the assets and the value of the in-process research and development indefinite-lived intangible assets as of December 31, 2025, totaled $7,219,000.
Auditing the Company’s annual impairment assessment was complex and highly judgmental due to the significant judgment required in determining whether the intangibles were valued in a reasonable and appropriate manner. This required a high degree of auditor judgment, subjectivity and effort in performing procedures and evaluating audit evidence to evaluate management’s assessment in evaluating these indefinite-lived intangible assets for impairment. These procedures included among others: (1) evaluating management’s process for evaluating impairment, (2) evaluating the factors assessed by management (3) evaluating the methods for valuing the impairment that was recorded (4) evaluating other relevant factors in making our own determination, and (5) evaluating and discussing considerations and conclusions made by management.
/s/
We have served as the Company’s auditor since 2023
March 31, 2026
| 35 |
CO-DIAGNOSTICS, INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
| December 31, 2025 | December 31, 2024 | |||||||
| Assets | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | $ | ||||||
| Marketable investment securities | - | |||||||
| Accounts receivable, net | ||||||||
| Inventory, net | ||||||||
| Income taxes receivable | - | |||||||
| Prepaid expenses and other current assets | ||||||||
| Total current assets | ||||||||
| Property and equipment, net | ||||||||
| Operating lease right-of-use asset | ||||||||
| Intangible assets, net | ||||||||
| Investment in joint ventures | ||||||||
| Total assets | $ | $ | ||||||
| Liabilities and stockholders’ equity | ||||||||
| Current liabilities | ||||||||
| Accounts payable | $ | $ | ||||||
| Accrued expenses | ||||||||
| Operating lease liability, current | ||||||||
| Contingent consideration liabilities, current | ||||||||
| Deferred revenue | ||||||||
| Total current liabilities | ||||||||
| Long-term liabilities | ||||||||
| Income taxes payable | - | |||||||
| Operating lease liability | ||||||||
| Contingent consideration liabilities | - | |||||||
| Total long-term liabilities | ||||||||
| Total liabilities | ||||||||
| Commitments and contingencies (Note 13) | - | - | ||||||
| Stockholders’ equity | ||||||||
| Convertible preferred stock, $ | - | - | ||||||
| Common stock, $ | ||||||||
| Treasury stock, at cost; | ( | ) | ( | ) | ||||
| Additional paid-in capital | ||||||||
| Accumulated other comprehensive income | - | |||||||
| Accumulated deficit | ( | ) | ( | ) | ||||
| Total stockholders’ equity | ||||||||
| Total liabilities and stockholders’ equity | $ | $ | ||||||
See accompanying notes to consolidated financial statements.
| 36 |
CO-DIAGNOSTICS, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
| 2025 | 2024 | |||||||
| Years Ended December 31, | ||||||||
| 2025 | 2024 | |||||||
| Product revenue | $ | $ | ||||||
| Grant revenue | ||||||||
| Total revenue | ||||||||
| Cost of revenue | ||||||||
| Gross profit | ||||||||
| Operating expenses | ||||||||
| Sales and marketing | ||||||||
| General and administrative | ||||||||
| Research and development | ||||||||
| Depreciation and amortization | ||||||||
| Impairment charges | - | |||||||
| Total operating expenses | ||||||||
| Loss from operations | ( | ) | ( | ) | ||||
| Other income, net | ||||||||
| Interest income, net | ||||||||
| Realized gain on investments | ||||||||
| Gain (loss) on disposition of assets | ( | ) | ||||||
| Gain on remeasurement of acquisition contingencies | ||||||||
| Loss on equity method investment in joint ventures | ( | ) | ( | ) | ||||
| Total other income, net | ||||||||
| Loss before income taxes | ( | ) | ( | ) | ||||
| Income tax provision (benefit) | ( | ) | ||||||
| Net loss | $ | ( | ) | $ | ( | ) | ||
| Other comprehensive income (loss) | ||||||||
| Change in net unrealized gains (losses) on marketable securities, net of tax | ( | ) | ||||||
| Total other comprehensive income (loss) | $ | ( | ) | $ | ||||
| Comprehensive loss | $ | ( | ) | $ | ( | ) | ||
| Loss per common share: | ||||||||
| Basic and Diluted | $ | ( | ) | $ | ( | ) | ||
| Weighted average shares outstanding: | ||||||||
| Basic and Diluted | ||||||||
See accompanying notes to consolidated financial statements.
| 37 |
CO-DIAGNOSTICS, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENT OF CHANGES IN STOCKHOLDERS’ EQUITY
| Shares | Amount | Shares | Amount |
Stock |
Capital |
Income | (Deficit) |
Equity | ||||||||||||||||||||||||||||
Convertible Preferred Stock | Common Stock | Treasury | Additional Paid-in | Accumulated Other Comprehensive | Accumulated Earnings | Total Stockholders’ | ||||||||||||||||||||||||||||||
| Shares | Amount | Shares | Amount |
Stock |
Capital |
Income | (Deficit) |
Equity | ||||||||||||||||||||||||||||
| Balance as of December 31, 2023 | - | $ | - | $ | $ | ( | ) | $ | $ | $ | $ | | ||||||||||||||||||||||||
| Issuance of common stock related to at-the-market offering, net of offering costs | - | - | - | - | - | |||||||||||||||||||||||||||||||
| Stock-based compensation expense | - | - | - | - | - | |||||||||||||||||||||||||||||||
| Other comprehensive loss, net of tax | - | - | - | - | - | - | - | |||||||||||||||||||||||||||||
| Net loss | - | - | - | - | - | - | - | ( | ) | ( | ) | |||||||||||||||||||||||||
| Balance as of December 31, 2024 | - | $ | - | $ | $ | ( | ) | $ | $ | $ | ( | ) | $ | |||||||||||||||||||||||
| Balance | - | $ | - | $ | $ | ( | ) | $ | $ | $ | ( | ) | $ | |||||||||||||||||||||||
| Common stock issued for option exercises | - | - | - | - | - | |||||||||||||||||||||||||||||||
| Issuance of common stock related to at-the-market offering, net of offering costs | - | - | - | - | - | |||||||||||||||||||||||||||||||
| Stock-based compensation expense | - | - | - | - | - | |||||||||||||||||||||||||||||||
| Issuance of common stock related to financial advisory services | - | - | - | - | - | |||||||||||||||||||||||||||||||
| Issuance of common stock related to registered direct offering, net of offering costs | - | - | - | - | - | |||||||||||||||||||||||||||||||
| Other comprehensive loss, net of tax | - | - | - | - | - | - | ( | ) | - | ( | ) | |||||||||||||||||||||||||
| Net loss | - | - | - | - | - | - | - | ( | ) | ( | ) | |||||||||||||||||||||||||
| Balance as of December 31, 2025 | - | $ | - | $ | $ | ( | ) | $ | $ | - | $ | ( | ) | $ | ||||||||||||||||||||||
| Balance | - | $ | - | $ | $ | ( | ) | $ | $ | - | $ | ( | ) | $ | ||||||||||||||||||||||
See accompanying notes to consolidated financial statements.
| 38 |
CO-DIAGNOSTICS, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
| 2025 | 2024 | |||||||
| Years Ended December 31, | ||||||||
| 2025 | 2024 | |||||||
| Cash flows from operating activities | ||||||||
| Net loss | $ | ( | ) | $ | ( | ) | ||
| Adjustments to reconcile net loss to cash used in operating activities: | ||||||||
| Depreciation and amortization | ||||||||
| Impairment charges | - | |||||||
| Stock-based compensation expense | ||||||||
| Common stock issued for financial advisory services | - | |||||||
| Change in fair value of acquisition contingencies | ( | ) | ( | ) | ||||
| Non-cash lease expense | ( | ) | ||||||
| Realized gain on investments | ( | ) | ( | ) | ||||
| Loss from equity method investment | ||||||||
| (Gain) loss on disposition of assets | ( | ) | ||||||
| Recoveries of credit losses | ( | ) | ( | ) | ||||
| Inventory obsolescence expense (recovery) | ( | ) | ||||||
| Changes in assets and liabilities: | ||||||||
| Accounts receivable | ( | ) | ||||||
| Prepaid expenses and other assets | ||||||||
| Inventory | ||||||||
| Deferred revenue | ( | ) | ( | ) | ||||
| Income taxes payable | ( | ) | ||||||
| Accounts payable, accrued expenses and other liabilities | ( | ) | ||||||
| Net cash used in operating activities | ( | ) | ( | ) | ||||
| Cash flows from investing activities | ||||||||
| Purchases of property and equipment | ( | ) | ( | ) | ||||
| Proceeds from maturities of marketable investment securities | ||||||||
| Purchases of marketable securities | ( | ) | ( | ) | ||||
| Investment in joint ventures | ( | ) | ( | ) | ||||
| Net cash provided by investing activities | ||||||||
| Cash flows from financing activities | ||||||||
| Proceeds from exercise of options | - | |||||||
| Issuance of common stock related to at-the-market offering, net of offering costs | ||||||||
| Issuance of common stock related to registered direct offering, net of offering costs | - | |||||||
| Net cash provided by financing activities | ||||||||
| Net increase (decrease) in cash and cash equivalents | ( | ) | ||||||
| Cash and cash equivalents at beginning of period | ||||||||
| Cash and cash equivalents at end of period | $ | $ | ||||||
| Supplemental disclosure of cash flow information | ||||||||
| Cash received for income taxes | $ | ( | ) | $ | - | |||
| Supplemental disclosure of non-cash investing and financing transactions | ||||||||
| Receivable from issuance of common stock, collected in 2025 | $ | - | $ | |||||
See accompanying notes to consolidated financial statements.
| 39 |
CO-DIAGNOSTICS, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
YEARS ENDED DECEMBER 31, 2025 AND 2024
Note 1 – Overview and Basis of Presentation
Description of Business
Co-Diagnostics, Inc., a Utah corporation (the “Company” or “CODX”), is a molecular diagnostics company that develops, manufactures and markets state-of-the-art diagnostics technologies. The Company’s technologies are utilized for tests that are designed using the detection and/or analysis of nucleic acid molecules (DNA or RNA). The Company also uses its proprietary technology to design specific tests for its Co-Dx™ PCR platform and to locate genetic markers for use in applications other than infectious disease. In connection with the sale of our tests we may sell diagnostic equipment from other manufacturers as self-contained lab systems.
Use of Estimates
The preparation of financial statements in conformity with generally accepted accounting principles requires management to make estimates and assumptions that affect the amounts reported in the financial statements and the accompanying notes. Such estimates include inventories, receivables and other long-lived assets, legal and regulatory contingencies, income taxes, share based arrangements, and others. These estimates and assumptions are based on management’s best estimates and judgments. Actual amounts and results could differ from those estimates.
Basis of Presentation
The accompanying audited consolidated financial statements of Co-Diagnostics, Inc. and its wholly owned subsidiaries have been prepared to reflect the financial position, results of operations and cash flows of the Company and have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”). All intercompany balances and transactions have been eliminated.
Reverse Stock Split
On January 1, 2026, the Company effected a
Proportionate adjustments were made to the number of shares of common stock underlying the Company’s outstanding equity awards and warrants, as well as to the applicable exercise prices. All historical and per-share information has been retroactively adjusted to reflect the Reverse Stock Split.
Liquidity and Going Concern
In its annual report on Form 10-K for the year ended December 31, 2024, the Company concluded, in accordance with the criteria identified in Accounting Standards Codification (“ASC”) 205-40, Going Concern, (“ASC 205-40”), that substantial doubt existed about the Company’s ability to continue as a going concern. This conclusion was driven by the Company’s historical operating losses, negative cash flows from operations, and existing liquidity position at that time.
During the year ended December 31, 2025, the Company completed various transactions designed to improve its liquidity and capital structure, primarily through the sale of shares under the Company’s ATM Agreement and through two registered direct offerings of common stock.
Despite these actions, management determined that the conditions that raised substantial doubt in the prior year have not been alleviated and therefore has concluded that substantial doubt continues to exist about the Company’s ability to continue as a going concern for 12 months from the date these consolidated financial statements are issued.
The Company’s ability to obtain additional financing in equity capital markets is subject to several factors, including market and economic conditions, our performance and investor sentiment with respect to us and our industry. Accordingly, there can be no assurance that the Company will be able to raise a sufficient amount of additional capital to fund operations with terms acceptable to the Company, or at all. Because certain elements of management’s plans to mitigate the conditions that raised substantial doubt about the Company’s ability to continue as a going concern are outside of the Company’s control, including the ability to raise capital through equity or other financings, those elements cannot be considered probable according to ASC 205-40, and therefore cannot be considered in the evaluation of mitigating factors.
The consolidated financial statements as of December 31, 2025, have been prepared under the assumption that the Company will continue as a going concern for the next 12 months after these financial statements are issued, and that contemplates the realization of assets and satisfaction of liabilities and commitments in the normal course of business. The Company’s ability to continue as a going concern is dependent upon its uncertain ability to obtain additional capital, reduce expenditures, and execute on its business plans. These consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Note 2 – Summary of Significant Accounting Policies
Operating Segments
The Company operates as one operating segment. Operating segments are defined as components of an entity for which separate financial information is regularly evaluated by the chief operating decision maker (“CODM”), which is the Company’s Chief Executive Officer, in deciding how to allocate resources and assess performance. The Company’s CODM evaluates financial information and resources and assesses the performance of these resources on a consolidated basis. There is no expense or asset information that is supplemental to information disclosed within the consolidated financial statements, that is regularly provided to the CODM. The allocation of resources and assessment of performance of the operating segment is based on consolidated net loss and functional expenses as reported on our consolidated statements of operations and comprehensive loss. Because the Company operates as one operating segment, financial segment information, including expense and asset information, can be found in the consolidated financial statements. All material long-lived assets are based in the United States and India.
Reclassifications
Certain prior year amounts have been reclassified to conform with the current year’s presentation. These reclassifications have no impact on the previously reported results.
Revision of Previously Issued Financial Statements
During the preparation of the Company’s
consolidated financial statements for the year ended December 31, 2025, the Company identified an immaterial error in its previously
issued consolidated financial statements for the year ended December 31, 2024. The error related to the accounting for the
Company’s joint venture investment. Specifically, the Company had overstated its investment in joint
ventures balance and accumulated deficit balance by $
The following table summarizes the effect of the revision on the previously reported line items in the Company’s December 31, 2024 consolidated balance sheet:
Schedule of revision of previously reported line items
| Balance Sheet | As Previously | |||||||||||
| Line Item | Reported | Revision | As Revised | |||||||||
| Investment in joint ventures | $ | $ | ( | ) | $ | |||||||
| Accumulated deficit | $ | ( | ) | $ | ( | ) | $ | ( | ) | |||
There was no impact on the Company’s consolidated statements of operations and comprehensive loss, consolidated statements of cash flows, or loss per share for any period presented.
Cash and Cash Equivalents
Cash and cash equivalents consist of cash on hand, money market funds and highly liquid investments with an original maturity date of 90 days or less from the date of purchase. The fair value of cash equivalents approximated their carrying value as of December 31, 2025, and December 31, 2024. The Company has its cash and cash equivalents with a large creditworthy financial institution and the balance exceeded federally insured limits. The Company has not experienced any losses in such accounts, and management believes the Company is not exposed to any significant credit risk on cash and cash equivalents.
| 40 |
Marketable Investment Securities
The Company’s marketable investment securities are comprised of investments in certificates of deposit and U.S. Treasury bills and notes. The Company designates investments in debt securities as available-for-sale. Available-for-sale debt securities with original maturities of three months or less from the date of purchase are classified within cash and cash equivalents. Available-for-sale debt securities with original maturities longer than three months are available to fund current operations and are classified as marketable investment securities, within current assets on the consolidated balance sheets. The Company may sell these securities at any time for use in its current operations or for other purposes, even prior to maturity. Available-for-sale debt securities are reported at fair value with the related unrealized gains and losses included in accumulated other comprehensive income (loss), a component of stockholders’ equity, net of tax. Realized gains and losses on the sale of marketable securities are determined using the average cost method on a first-in, first-out basis and recorded in total other income (expense), net in the consolidated statements of operations and comprehensive loss.
The available-for-sale debt securities are subject to a periodic impairment review. For investments in an unrealized loss position, the Company writes down the amortized cost basis of the investment if it is more likely than not that the Company will be required or will intend to sell the investment before recovery of its amortized cost basis. For investments not likely to be sold before recovery of the amortized cost basis, the Company determines whether a credit loss exists by considering information about the collectability of the instrument, current market conditions, and reasonable and supportable forecasts of economic conditions. The Company recognizes an allowance for credit losses up to the amount of the unrealized loss when appropriate. Allowances for credit losses and write-downs are recognized in total other income (expense), net, and unrealized losses not related to credit losses are recognized in accumulated other comprehensive income (loss). There are no allowances for credit losses recorded for the periods presented.
Accounts Receivable
Trade
accounts receivable are recorded at the invoiced amount (net of allowance) and do not bear interest. The Company maintains an allowance
for credit losses for amounts the Company does not expect to collect. In establishing the required allowance, management considers historical
losses, current market condition, customers’ financial condition, the age of receivables, and current payment patterns. Account
balances are written off against the allowance once the receivable is deemed uncollectible. Recoveries of trade receivables previously
written off are recorded when collected. At December 31, 2025, total accounts receivable was $
Equity-Method Investments
Our equity-method investments are initially recorded at cost and are included in other long-term assets in the accompanying consolidated balance sheet. We adjust the carrying value of our investment based on our share of the earnings or losses in the periods which they are reported by the investee until the carrying amount is zero. The earnings or losses are included in other income in the accompanying consolidated statements of operations.
Inventory
Inventory
is stated at the lower of cost or net-realizable value. Inventory cost is determined on a first-in first-out basis that approximates
average cost in accordance with ASC 330-10-30-12. At December 31, 2025, the Company had $
| 41 |
Intangible Assets
Indefinite-lived intangible assets are not amortized, but rather tested for impairment at least annually on December 31, or more often if and when circumstances indicate that the carrying value may not be recoverable. Finite-lived intangible assets are amortized over their useful lives.
The assessment of the Company’s indefinite lived intangible asset involves comparing the fair value of the asset, determined using the income approach which is based on discounted cash flow techniques, to the carrying value of the asset. The fair value determination is based on the concept of evaluating the highest and best use of the asset in the hands of a market participant and considers the current use and any other use that is financially feasible, justifiable, and reasonably probable. If the fair value is less than the carrying value, an impairment expense is recorded for the difference between those values.
During 2025, the Company identified impairment indicators
for its in-process research and development intangible assets, primarily due to a significant and sustained decline in our stock price
and market capitalization compared to the assets’ net book value. The Company remeasured the fair value of these assets and recognized
non-cash impairment charges of $
Long-lived Assets
Long-lived assets, such as property and equipment, are stated at cost less accumulated depreciation and amortization. Depreciation is provided using the straight-line method over the estimated useful lives of the property, generally from three to five years. Repairs and maintenance costs are expensed as incurred except when such repairs significantly add to the useful life or productive capacity of the asset, in which case the repairs are capitalized.
For in-process research and development projects acquired in business combinations, the in-process research and development project is capitalized and evaluated for impairment until the development process has been completed. Once the development process has been completed the asset will be amortized over its remaining estimated useful life. The Company reviews its long-lived assets, including property and equipment, indefinite-lived and finite-lived intangible assets, and right-of-use (“ROU”) assets, for impairment whenever an event or change in facts and circumstances indicates that their carrying amounts may not be recoverable. Recoverability of these assets is measured by comparing the carrying amount to the estimated undiscounted future cash flows expected to be generated. If the carrying amount exceeds the undiscounted cash flows, the assets are determined to be impaired and an impairment charge is recognized as the amount by which the carrying amount exceeds fair value.
Leases
Leases with a term longer than 12 months are recognized on the balance sheet as ROU assets and lease liabilities and are classified as either finance or operating leases, with that classification affecting the pattern and classification of expense recognition in the statement of operations and comprehensive loss. ROU assets are evaluated for impairment as a long-lived asset.
Revenue Recognition
The Company generates revenue from product sales and license sales. The Company recognizes revenue when all of the following criteria are satisfied: (i) identification of the promised goods or services in the contract; (ii) determination of whether the promised goods or services are performance obligations, including whether they are distinct in the context of the contract; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations; and (v) recognition of revenue when, or as the Company satisfies each performance obligation. Based on the criteria above, the Company typically recognizes revenue upon delivery.
The Company constrains revenue by giving consideration to factors that could otherwise lead to a probable reversal of revenue. The Company records any payments received from customers prior to the Company fulfilling its performance obligation(s) as deferred revenue.
Grant Revenue
The
Company may submit applications to receive grant funding from governmental and non-governmental entities. The Company accounts for
grants by analogizing to the contribution accounting model under ASC 958-605, Not-for-Profit Entities (“ASC 958”).
Revenues from grants, contracts, and awards provided by governmental and non-governmental agencies are recorded based upon the terms
of the specific agreements. The Company recognizes grant funding without conditions or continuing performance obligations as revenue
in the consolidated statements of operations and comprehensive income (loss). The Company recognizes grant funding with conditions
or continuing performance obligations as deferred revenue in the consolidated balance sheets if the conditions or performance
obligations have not yet been met. The Company recognized grant funding revenue of $
Deferred Revenue
Deferred revenue primarily consists of payments received from customers prior to the Company fulfilling its performance obligation of providing the product. When this occurs, the Company records a contract liability as deferred revenue. Deferred revenue is recognized as revenue as the related performance obligations are satisfied.
| 42 |
Research and Development
Research
and development costs are expensed when incurred. The Company recorded $
Stock-based Compensation
The Company has granted stock-based awards, including restricted stock, stock options, stock warrants and restricted stock units (“RSUs”), to its employees, certain consultants and members of its board of directors. The Company records stock-based compensation based on the grant date fair value of the awards and recognizes the fair value of those awards as expense using the straight-line method over the requisite service period of the award. The Company estimates the grant date fair value of stock options using the Black-Scholes option-pricing model. When an award is forfeited prior to the vesting date, the Company recognizes an adjustment for the previously recognized expense in the period of the forfeiture.
Income Taxes
The Company accounts for income taxes in accordance with the liability method of accounting for income taxes. Under this method, deferred income tax assets and deferred income tax liabilities represent the tax effect of temporary differences between financial reporting and tax reporting measured at enacted tax rates in effect for the year in which the differences are expected to reverse. The Company recognizes only the impact of tax positions that, based on their technical merits, are more likely than not to be sustained upon an audit by the taxing authority.
Valuation allowances are provided when it is more-likely-than-not that some or all of the deferred income tax assets may not be realized. In assessing the need for a valuation allowance, the Company has considered its historical levels of income, expectations of future taxable income and ongoing tax planning strategies.
Developing the provision for income taxes, including the effective tax rate and analysis of potential tax exposure items, if any, requires significant judgment and expertise in federal and state income tax laws, regulations and strategies, including the determination of deferred income tax assets and liabilities and any estimated valuation allowances deemed necessary to value deferred income tax assets. Judgments and tax strategies are subject to audit by various taxing authorities. The Company has uncertain income tax positions in the consolidated financial statements, and adverse determinations by these taxing authorities could have a material adverse effect on the consolidated financial positions, result of operations, or cash flows.
Net Loss per Share
Basic net loss per common share is computed by dividing net loss applicable to common shareholders by the weighted average number of shares outstanding during each period.
Diluted net loss per share is computed by dividing net loss attributable to common stockholders by the weighted-average number of shares of common stock outstanding during the period increased by common shares that could be issued upon conversion or exercise of other outstanding securities to the extent those additional common shares would be dilutive. The dilutive effect of potentially dilutive securities is reflected in diluted net loss per share by application of the treasury stock method. During periods when the Company is in a net loss position, basic net loss per share is the same as diluted net loss per share as the effects of potentially dilutive securities are anti-dilutive.
Comprehensive Loss
Comprehensive loss is comprised of net loss and unrealized gains and losses on marketable securities, net of income taxes.
Concentrations Risk and Significant Customers
The
Company had certain customers which were each responsible for generating
| 43 |
Two
customers accounted for more than
Recently Issued Accounting Standards
From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (“FASB”) that are adopted by the Company as of the specified effective date. If not discussed, management believes that the impact of recently issued standards, which are not yet effective, will not have a material impact on the Company’s financial statements upon adoption.
In November 2023, the FASB issued Accounting Standards Update (“ASU”) 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures, which improves reportable segment disclosure requirements, primarily through enhanced disclosures about significant segment expenses. The standard is effective for full year 2024 reporting, and for interim reporting beginning in 2025. The adoption of this ASU did not change the way the Company evaluates its reportable segments and, as a result, did not have a material impact on the Company’s segment-related disclosures.
In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, which requires public entities, on an annual basis, to provide disclosure of specific categories in the rate reconciliation, as well as disclosure of income taxes paid disaggregated by jurisdiction. The standard is effective for the Company for full year 2025 reporting, with early adoption permitted. The Company adopted ASU 2023-09 prospectively for the year ended December 31, 2025, and applied the new disclosure requirements.
In November 2024, the FASB issued ASU 2024-03, Income Statement (Subtopic 220-40): Reporting Comprehensive Income - Expense Disaggregation Disclosures, which requires an entity to disclose on an annual and interim basis, disaggregated information about specific income statement expense categories. The guidance should be applied prospectively with the option to apply the standard retrospectively. The standard becomes effective for the Company for full year 2027 reporting. The Company is currently evaluating the impact of this new standard on its consolidated financial statements.
In July 2025, the FASB issued ASU 2025-05, Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses for Accounts Receivable and Contract Assets, which provides all entities with a practical expedient when estimating expected credit losses for current accounts receivable and current contract assets arising from transactions accounted for under Topic 606. Early adoption is permitted and entities should apply the practical expedient, if elected, prospectively to financial statements issued for reporting periods after the effective date. The standard becomes effective for the Company for interim and full year 2026 reporting. The Company is currently evaluating the impact of this new standard on its consolidated financial statements.
In December 2025, the FASB issued ASU 2025-10, Government Grants (Topic 832): Accounting for Government Grants Received by Business Entities, which provides authoritative guidance for the accounting and presentation of government grants received by business entities, distinguishing between grants related to assets and grants related to income. Early adoption is permitted and entities may apply the standard using a modified prospective, modified retrospective, or full retrospective transition approach, subject to the specific criteria outlined in the ASU. The standard becomes effective for the Company for full year 2029 reporting. The Company is currently evaluating the impact of this new standard on its consolidated financial statements.
In December 2025, the FASB issued ASU 2025-11, Interim Reporting (Topic 270): Narrow-Scope Improvements, which clarifies and improves the guidance in Accounting Standards Codification Topic 270, Interim Reporting. Early adoption is permitted and entities may apply the standard prospectively or retrospectively. The standard becomes effective for the Company for interim 2028 reporting. The Company is currently evaluating the impact of this new standard on its consolidated financial statements.
In December 2025, FASB issued ASU 2025-12, Codification Improvements, which includes narrow-scope amendments to the FASB Accounting Standards Codification to clarify, correct errors, and make minor improvements to existing U.S. GAAP. This standard becomes effective for the Company for interim and full year 2027 reporting. As the amendments are not expected to introduce new recognition or measurement principles, the Company does not expect a material impact on its consolidated financial statements related to ASU 2025-12.
Note 3 – Cash, Cash Equivalents, and Financial Instruments
The following table shows the Company’s cash, cash equivalents, and marketable investment securities by significant investment category:
Schedule of Cash, Cash Equivalents and Marketable Investment Securities
| December 31, 2025 | ||||||||||||||||||||
| Adjusted Cost | Total Unrealized Gains / (Losses) | Fair Value | Cash and Cash Equivalents | Marketable Investment Securities | ||||||||||||||||
| Cash | $ | $ | - | $ | $ | $ | - | |||||||||||||
| Total | $ | $ | - | $ | $ | $ | - | |||||||||||||
| December 31, 2024 | ||||||||||||||||||||
| Adjusted Cost | Total Unrealized Gains / (Losses) | Fair Value | Cash and Cash Equivalents | Marketable Investment Securities | ||||||||||||||||
| Cash | $ | $ | - | $ | $ | $ | - | |||||||||||||
| Level 2: | ||||||||||||||||||||
| U.S. treasury securities | - | |||||||||||||||||||
| Subtotal | - | |||||||||||||||||||
| Total | $ | $ | $ | $ | $ | |||||||||||||||
Note 4 – Fair Value Measurements
The Company measures and records certain financial assets and liabilities at fair value on a recurring basis. Fair value is based on the price that would be received from selling an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date.
The following three levels of inputs are used to measure the fair value of financial assets and liabilities:
Level 1: Quoted market prices in active markets for identical assets or liabilities.
Level 2: Observable market-based inputs or unobservable inputs that are corroborated by market data.
Level 3: Unobservable inputs that are not corroborated by market data.
| 44 |
The following table summarizes the assets and liabilities measured at fair value on a recurring basis as of December 31, 2025 and December 31, 2024, by level within the fair value hierarchy:
Schedule of Fair Value Assets and Liabilities
| December 31, 2025 | ||||||||||||||||
| (Level 1) | (Level 2) | (Level 3) | Total | |||||||||||||
| Liabilities: | ||||||||||||||||
| Cash equivalents | ||||||||||||||||
| Marketable securities (U.S. treasury bills and notes) | ||||||||||||||||
| Total assets measured at fair value | ||||||||||||||||
| Contingent consideration - common stock | $ | - | $ | - | $ | $ | ||||||||||
| Contingent consideration - warrants | ||||||||||||||||
| Total liabilities measured at fair value | $ | - | $ | - | $ | $ | ||||||||||
| December 31, 2024 | ||||||||||||||||
| (Level 1) | (Level 2) | (Level 3) | Total | |||||||||||||
| Assets: | ||||||||||||||||
| Cash equivalents | $ | $ | - | $ | - | $ | ||||||||||
| Marketable securities (U.S. treasury bills and notes) | - | - | ||||||||||||||
| Total assets measured at fair value | $ | $ | $ | - | $ | |||||||||||
| Liabilities: | ||||||||||||||||
| Contingent consideration - common stock | $ | - | $ | - | $ | $ | ||||||||||
| Contingent consideration - warrants | - | - | ||||||||||||||
| Total liabilities measured at fair value | $ | - | $ | - | $ | $ | ||||||||||
The Company’s financial instruments that are measured at fair value on a recurring basis consist of certificates of deposit and U.S. treasury bills and notes as of December 31, 2025 and 2024, respectively.
In connection with previous acquisitions, the Company recorded a liability for contingent consideration in the form of shares of common stock and warrants to purchase common stock, both to be issued when certain milestones are achieved. The fair value of contingent consideration is calculated using a discounted probability weighted valuation model. Discount rates used in such calculations are a significant assumption that are not observed in the market, and therefore, the resulting fair value represents a Level 3 measurement.
The changes for Level 3 items measured at fair value on a recurring basis are as follows:
Schedule of Changes in the Fair Value Measurement
| Fair value as of December 31, 2024 | $ | |||
| Change in fair value of contingent consideration issued for business acquisitions | ( | ) | ||
| Fair value as of December 31, 2025 | $ |
| 45 |
The fair value of the contingent consideration is based on the fair value of the contingent consideration-common stock and contingent consideration-warrants. The fair value of the contingent consideration-common stock is equal to the probability-adjusted value of the Company’s common stock as of the valuation date. The fair value of the contingent consideration-warrants is equal to the probability adjusted value of a call option with terms consistent with the terms of the warrants as of the valuation date. Prior to the probability adjustments, the warrants were valued based on the following inputs:
Schedule of Contingent Consideration Common Stock and Warrants
| December 31, 2025 | December 31, 2024 | |||||||
| Stock price | $ | $ | ||||||
| Strike price | $ | $ | ||||||
| Volatility | % | % | ||||||
| Risk-free rate | % | % | ||||||
| Expected term (years) | ||||||||
Fair Value of Other Financial Instruments
The carrying amounts of certain financial instruments, including cash held in banks, accounts receivable, notes receivable, accounts payable, accrued liabilities, and other liabilities approximate fair value due to their short-term maturities and are excluded from the fair value tables above.
Note 5 – Property and Equipment
Property and equipment, net consisted of the following:
Schedule of Property and Equipment
| Estimated | December 31, | |||||||||
| Useful Lives in years | 2025 | 2024 | ||||||||
| Lab equipment | $ | $ | ||||||||
| Leasehold improvements | ||||||||||
| Office equipment, furniture and other | ||||||||||
| Less accumulated depreciation and amortization | ( | ) | ( | ) | ||||||
| Fixed assets, net | $ | $ | ||||||||
Note 6 – Intangible Assets
Intangible assets, net consisted of the following:
Schedule of Intangible Assets, Net
| December 31, 2025 | ||||||||||||||
| Weighted-Average | Gross | Net | ||||||||||||
| Useful Life | Carrying | Accumulated | Carrying | |||||||||||
| (in Years) | Amount | Amortization | Amount | |||||||||||
| In-process research and development | $ | $ | - | $ | ||||||||||
| Non-competition agreements | ( | ) | - | |||||||||||
| Total intangible assets | $ | $ | ( | ) | $ | |||||||||
| December 31, 2024 | ||||||||||||||
| Weighted-Average | Gross | Net | ||||||||||||
| Useful Life | Carrying | Accumulated | Carrying | |||||||||||
| (in Years) | Amount | Amortization | Amount | |||||||||||
| In-process research and development | $ | $ | - | $ | ||||||||||
| Non-competition agreements | ( | ) | - | |||||||||||
| Total intangible assets | $ | $ | ( | ) | $ | |||||||||
The Company completed its impairment test for the in-process research and development during the fourth quarter of 2025, resulting in a partial impairment of the intangible asset which is reflected in impairment charges on the consolidated statements of operations and comprehensive loss for the year ended December 31, 2025. The Company did not record any impairment during the year ended December 31, 2024.
Changes in the Company’s in-process research and development for the year ended December 31, 2025 were as follows:
Schedule of Research and Development
| Balance as of December 31, 2024 | $ | |||
| Impairment of in-process research and development | ( | ) | ||
| Balance as of December 31, 2025 | $ |
| 46 |
Note 7 – Investment in Joint Ventures
On October 27, 2025, the Company formed
a new joint venture, CoMira Diagnostics (“CoMira”), with Arabian Eagle Manufacturing to research, develop, manufacture, assemble,
distribute, and commercialize the Company’s technologies and intellectual property within the Kingdom of Saudi Arabia and other
countries throughout the Middle East and North Africa. The Company invested an initial $
Note 8 - Accrued Expenses
Accrued expenses consisted of the following:
Schedule of Accrued Expenses
| December 31, 2025 | December 31, 2024 | |||||||
| Payroll liabilities | $ | $ | ||||||
| Legal fees | ||||||||
| Other accrued liabilities | ||||||||
| Total accrued expenses | $ | $ | ||||||
Note 9 – Revenue
The following table sets forth revenue by geographic area:
Summary of Revenue by Geographic Area
| Years Ended December 31, | ||||||||
| 2025 | 2024 | |||||||
| United States | ||||||||
| Product revenue | $ | $ | ||||||
| Grant revenue | ||||||||
| Total United States | ||||||||
| Rest of World | ||||||||
| Product revenue | ||||||||
| Grant revenue | - | - | ||||||
| Total Rest of World | ||||||||
| Total | $ | $ | ||||||
| Revenue | $ | $ | ||||||
| Percentage of revenue by area: | ||||||||
| United States | % | % | ||||||
| Rest of World | % | % | ||||||
Deferred Revenue
Changes in the Company’s deferred revenue balance for the years ended December 31, 2025 and 2024 were as follows:
Schedule of Deferred Revenue
| Balance as of December 31, 2023 | $ | |||
| Revenue recognized included in deferred revenue balance at the beginning of the period | ( | ) | ||
| Decrease due to reclassification of previously deferred amounts | ( | ) | ||
| Balance as of December 31, 2024 | $ | |||
| Revenue recognized included in deferred revenue balance at the beginning of the period | ( | ) | ||
| Increase due to prepayments from customers | ||||
| Balance as of December 31, 2025 | $ |
Note 10 – Loss per Share
All share and per-share data, including basic and diluted loss per share and weighted average shares outstanding, have been retroactively adjusted to reflect the 1-for-30 reverse stock split effected on January 1, 2026, as if the reverse stock split had occurred at the beginning of the earliest period presented.
The following table reconciles the numerator and the denominator used to calculate basic and diluted loss per share for years ended December 31, 2025 and 2024:
Schedule of Basis and Diluted Earnings Per Share
| Years Ended December 31, | ||||||||
| 2025 | 2024 | |||||||
| Numerator | ||||||||
| Net loss, as reported | $ | ( | ) | $ | ( | ) | ||
| Denominator | ||||||||
| Weighted average shares, basic | ||||||||
| Dilutive effect of stock options, warrants and RSUs | - | - | ||||||
| Shares used to compute diluted loss per share | ||||||||
| Basic loss per share | $ | ( | ) | $ | ( | ) | ||
| Diluted loss per share | $ | ( | ) | $ | ( | ) | ||
| 47 |
The
computation of diluted loss per share for the years ended December 31, 2025 and December 31, 2024 also excludes approximately
As
a result of incurring a net loss for the years ended December 31, 2025 and 2024, respectively,
Note 11 – Stock-Based Compensation
Reverse Stock Split
On January 1, 2026, the Company effected a 1-for-30
reverse stock split of its common stock. The Reverse Stock Split did not change the par value
of the Company’s common stock, which remains $
Proportionate adjustments were made to the number of shares of common stock underlying the Company’s outstanding equity awards and warrants, as well as to the applicable exercise prices. All historical and per-share information has been retroactively adjusted to reflect the Reverse Stock Split.
Stock Incentive Plans
The
Company’s board of directors adopted, and shareholders approved, the Co-Diagnostics, Inc. Amended and Restated 2015 Long Term Incentive
Plan (the “Incentive Plan”) providing for the issuance of stock-based incentive awards to employees, officers, consultants,
directors and independent contractors. On August 31, 2022, the shareholders approved an increase in the number of awards available for
issuance under the Incentive Plan to an aggregate of
The
Incentive Plan expired on December 31, 2025. The Company’s board of directors adopted in March 2025, and in May 2025 shareholders
approved, the Co-Diagnostics, Inc. 2025 Equity Incentive Plan (the “2025 Plan”) providing for the issuance of stock-based
incentive awards to employees, officers, consultants, directors and independent contractors. At December 31, 2025, the number of awards
available for issuance under the 2025 Plan was
Stock Options
The following table summarizes option activity during the years ended December 31, 2025 and 2024:
Schedule of Option Activity
| Number of Options | Weighted Average Exercise Price | Weighted Average Fair Value | Weighted Average Remaining Contractual Life (Years) | |||||||||||||
| Outstanding at December 31, 2023 | $ | $ | ||||||||||||||
| Granted | - | - | - | |||||||||||||
| Expired | - | - | - | |||||||||||||
| Forfeited/Cancelled | - | - | - | |||||||||||||
| Exercised | - | - | - | |||||||||||||
| Outstanding at December 31, 2024 | $ | $ | ||||||||||||||
| Granted | - | - | - | |||||||||||||
| Expired | ( | ) | $ | $ | ||||||||||||
| Forfeited/Cancelled | - | - | - | |||||||||||||
| Exercised | ( | ) | ||||||||||||||
| Outstanding at December 31, 2025 | $ | $ | ||||||||||||||
| Exercisable at December 31, 2025 | $ | $ | ||||||||||||||
| 48 |
There
were
Restricted Stock Units
The grant date fair value of RSUs granted is determined using the closing market price of the Company’s common stock on the grant date with the associated compensation expense amortized over the vesting period of the awards. The following table sets forth the outstanding RSUs and related activity for the years ended December 31, 2025 and 2024:
Schedule of Outstanding Restricted Stock Units and Related Activity
| Number of RSUs | Weighted Average Grant Date Fair Value | |||||||
| Unvested at December 31, 2023 | $ | |||||||
| Granted | ||||||||
| Vested | ( | ) | ||||||
| Forfeited/Cancelled | ( | ) | ||||||
| Unvested at December 31, 2024 | $ | |||||||
| Granted | ||||||||
| Vested | ( | ) | ||||||
| Forfeited/Cancelled | ( | ) | ||||||
| Unvested at December 31, 2025 | $ | |||||||
As
of December 31, 2025, there was $
Warrants
The Company has issued warrants related to financings, acquisitions and as compensation to third parties for services provided. The Company estimates the fair value of issued warrants on the date of issuance as determined using a Black-Scholes pricing model. The Company amortizes the fair value of issued warrants using a vesting schedule based on the terms and conditions of each warrant if granted for services.
| 49 |
The following table summarizes warrant activity during the years ended December 31, 2025 and 2024:
Schedule of Warrant Activity
| Number of Warrants | Weighted Average Exercise Price | Weighted Average Fair Value | Weighted Average Remaining Contractual Life (Years) | ||||||||||||||
| Outstanding at December 31, 2023 | $ | $ | |||||||||||||||
| Granted | - | - | - | ||||||||||||||
| Expired | - | - | - | ||||||||||||||
| Forfeited/Cancelled | - | - | - | ||||||||||||||
| Exercised | - | - | - | ||||||||||||||
| Outstanding at December 31, 2024 | $ | $ | |||||||||||||||
| Granted | - | - | - | ||||||||||||||
| Expired | ( | ) | |||||||||||||||
| Forfeited/Cancelled | - | - | - | ||||||||||||||
| Exercised | - | - | - | ||||||||||||||
| Outstanding at December 31, 2025 | $ | $ | - | ||||||||||||||
There
were
There
are
Stock-Based Compensation Expense
The Company recognized stock-based compensation expense as follows:
Schedule of Recognized Stock-Based Compensation Expense
| Years Ended December 31, | ||||||||
| 2025 | 2024 | |||||||
| Cost of sales | $ | - | $ | |||||
| Sales and marketing | ||||||||
| General and administrative | ||||||||
| Research and development | ( | ) | ||||||
| Total stock-based compensation expense | $ | $ | ||||||
Note 12 – Income Taxes
The components of the provision (benefit) for income taxes consist of the following for the years ended December 31, 2025 and 2024:
Schedule of Components of Provision (Benefit) for Income Taxes
| 2025 | 2024 | |||||||
| Years Ended December 31, | ||||||||
| 2025 | 2024 | |||||||
| Current: | ||||||||
| Federal | $ | ( | ) | $ | ||||
| State | ( | ) | ||||||
| Total current | $ | ( | ) | $ | ||||
| Deferred: | ||||||||
| Federal | ( | ) | ( | ) | ||||
| State | ( | ) | ( | ) | ||||
| Change in valuation allowance | ||||||||
| Total deferred | - | - | ||||||
| Total income tax provision (benefit) | $ | ( | ) | $ | ||||
| 50 |
A reconciliation of income tax expense at the statutory federal income tax rate and income taxes as reflected in the financial statements is as follows:
Schedule of Benefit from Income Taxes and Effective Income Tax Rates
| Permanent differences: | ||||||||
| Year Ended December 31, 2025 | ||||||||
| U.S. federal statutory rate | $ | ( | ) | % | ||||
| State and local income taxes, net of federal income tax effect (a) | ( | ) | % | |||||
| Effect of changes in tax laws or rates enacted in the current period | % | |||||||
Tax credits | ||||||||
Research and development credits | ( | ) | % | |||||
Changes in valuation allowance | - | % | ||||||
Nontaxable or nondeductible items | ||||||||
| Stock based compensation | - | % | ||||||
| Contingent consideration remeasurement | ( | ) | % | |||||
| Other | - | % | ||||||
| Change in unrecognized tax benefits | ( | ) | % | |||||
| Other adjustments | ||||||||
| Federal refund due to OBBBA | ( | ) | % | |||||
| Change in deferred balances due to OBBBA | - | % | ||||||
| Other | - | % | ||||||
| Total provision for (benefit from) income taxes and effective tax rate | $ | ( | ) | % | ||||
| (a) |
| Permanent differences: | ||||||||
| Year Ended December 31, 2024 | ||||||||
| U.S. federal statutory rate | $ | ( | ) | % | ||||
| State and local income taxes, net of federal income tax effect | ( | ) | % | |||||
| Effect of changes in tax laws or rates enacted in the current period | % | |||||||
Tax credits | ||||||||
Research and development credits | ( | ) | % | |||||
Changes in valuation allowance | - | % | ||||||
Nontaxable or nondeductible Items | ||||||||
| Stock based compensation | - | % | ||||||
| Contingent consideration remeasurement | ( | ) | % | |||||
| Other | - | % | ||||||
| Change in unrecognized tax benefits | - | % | ||||||
Other adjustments | ||||||||
Federal refund due to OBBBA | - | % | ||||||
| Change in deferred balances due to OBBBA | - | % | ||||||
| Other | ( | ) | % | |||||
| Total provision for (benefit from) income taxes and effective tax rate | $ | - | % | |||||
On July 4, 2025, the One Big Beautiful Bill Act (OBBBA)
was signed into law, introducing a broad range of tax reform provisions affecting businesses, including extending and modifying certain
key Tax Cuts & Jobs Act provisions (both domestic and international), expanding certain Inflation Reduction Act incentives while accelerating
the phase-out of others. The Company filed amended federal income tax returns for tax years 2022 and 2023 under the OBBBA provisions and
subsequently received a $
The following table presents income taxes paid (net of refunds received) for the year ended December 31, 2025 as required by ASU 2023-09:
Schedule of Income Taxes Paid Net of Refunds Received
| Year Ended December 31, 2025 | ||||
| Cash paid for income taxes, net of refunds: | ||||
| Federal | $ | ( | ) | |
| State | ||||
| Total | $ | ( | ) | |
Net deferred tax assets and liabilities consist of the following components as of December 31, 2025 and 2024:
Schedule of Deferred Tax Assets and Liabilities
| Deferred compensation | 367,775 | 638,454 | ||||||
| December 31, | ||||||||
| 2025 | 2024 | |||||||
| Deferred tax assets: | ||||||||
| Accrued liabilities | $ | $ | ||||||
| Reserves and allowances | ||||||||
| Deferred compensation | ||||||||
| Section 174 costs | ||||||||
| Lease liability | ||||||||
| UNICAP | ||||||||
| Net operating loss carryforwards | ||||||||
| Research and development credits | ||||||||
| Other | ||||||||
| Total gross deferred tax assets | ||||||||
| Less valuation allowance | ( | ) | ( | ) | ||||
| Total deferred tax assets | ||||||||
| Deferred tax liabilities: | ||||||||
| Property and equipment, net | ( | ) | ( | ) | ||||
| Intangibles, net | ( | ) | ( | ) | ||||
| Prepaids | ( | ) | ( | ) | ||||
| Right of use asset | ( | ) | ( | ) | ||||
| Other comprehensive income | - | ( | ) | |||||
| Total deferred tax liabilities | ( | ) | ( | ) | ||||
| Net deferred tax asset (liability) | $ | - | $ | - | ||||
Valuation
allowances are established when necessary to reduce deferred tax assets, including temporary differences and net operating loss carryforwards,
to the amount expected to be realized in the future. FASB guidance indicates that forming a conclusion that a valuation allowance is
not needed is difficult when there is negative evidence such as cumulative losses in recent years. The Company had cumulative losses
from continuing operations for the three-year period ended December 31, 2025. The Company considered this negative evidence along with
all other available positive and negative evidence and concluded that, at December 31, 2025, it is more likely than not that the Company’s
U.S. deferred tax assets will not be realized. As of December 31, 2025, a valuation allowance has been recorded on the Company’s
deferred tax assets to recognize only the portion of the deferred tax asset that is more likely than not to be recognized. The Company’s
total valuation allowance was $
The following table summarizes changes in the valuation allowance during the years ended December 31, 2025 and 2024:
Schedule of Change in Valuation Allowance
| 2025 | 2024 | |||||||
| Years Ended December 31, | ||||||||
| 2025 | 2024 | |||||||
| Valuation allowance at beginning of year | $ | $ | ||||||
| Change in valuation allowance | ||||||||
| Valuation allowance at end of year | $ | $ | ||||||
At
December 31, 2025, the Company had federal net operating loss carryforwards of $
| 51 |
ASC
Topic 740-10-05 requires that the impact of a tax position be recognized in the financial statements if that position is more likely
than not of being sustained on audit, based on the technical merits of the position. Our unrecognized tax benefit balances included $
Schedule of Unrecognized Tax Benefits
| December 31, | ||||||||
| 2025 | 2024 | |||||||
| Unrecognized tax benefits at the beginning of the year | $ | $ | ||||||
| Gross increases - current year tax positions | ||||||||
| Gross increases - prior year tax positions | - | |||||||
| Gross decreases - prior year tax positions | ( | ) | ( | ) | ||||
| Unrecognized tax benefits at end of year | $ | $ | ||||||
| Interest and penalties in year-end balance | $ | - | $ | |||||
The Company is subject to taxation in the United States and other state jurisdictions. The tax years from December 31, 2022 through December 31, 2025 remain open to examination for federal income tax purposes and by the other major taxing jurisdictions to which the Company is subject. The Company is not currently under examination by any taxing authority.
Note 13 – Commitments and Contingencies
Lease Obligations
The Company leases administrative, R&D, sales and marketing and manufacturing facilities under non-cancellable operating leases.
For the years ended December 31, 2025 and 2024, respectively, components of lease expense are summarized as follows:
Schedule of Lease Expense
| 2025 | 2024 | |||||||
| Years Ended December 31, | ||||||||
| 2025 | 2024 | |||||||
| Operating lease costs | $ | $ | ||||||
| Short-term lease costs | - | |||||||
| Total lease costs | $ | $ | ||||||
As of December 31, 2025, the maturities of the Company’s lease liabilities are as follows:
Schedule of Maturities on Company Lease Liabilities
| Years Ending December 31, | ||||
| 2026 | $ | |||
| 2027 | ||||
| 2028 | ||||
| Thereafter | - | |||
| Total lease payments | ||||
| Less: imputed interest | ||||
| Present value of operating lease liabilities | ||||
| Less: current portion | ||||
| Long-term portion | $ | |||
| 52 |
Other information related to operating leases was as follows:
Schedule of Other Information Related to Operating Leases
| Year Ended December 31, 2025 | ||||
| Cash paid for operating leases included in operating cash flows | $ | |||
| Remaining lease term of operating leases | ||||
| Discount rate of operating leases | % | |||
Litigation
Liabilities for loss contingencies arising from claims, assessments, litigation, fines, and penalties and other sources are recorded when it is probable that a liability has been incurred and the amount can be reasonably estimated. Legal costs incurred in connection with loss contingencies are expensed as incurred.
The Company is a defendant in one class action suit claiming that the Company overstated the demand for its Logix Smart COVID-19 test and that the plaintiffs suffered losses when the Company’s stock dropped after the Company disclosed its financial results. The plaintiffs demand compensatory damages sustained as a result of the Company’s alleged wrongdoing in an amount to be proven at trial. The Company is also a party to three civil actions, two in the US and the other in the United Kingdom. Each of the civil actions is based on breach of contract claims against the Company. The Company believes these lawsuits are without merit and is defending the cases vigorously. The Company is unable to estimate a range of loss, if any, that could result were there to be an adverse final decision in these cases. As of the date of this report, the Company does not believe it is probable that these cases will result in an unfavorable outcome; however, if an unfavorable outcome were to occur in these cases, it is possible that the impact could be material to the Company’s results of operations in the period(s) in which any such outcome becomes probable and estimable.
Note 14 – Share Repurchase Program
In
March 2022, the Company’s board of directors authorized a share repurchase program that would allow the Company to repurchase up
to $
For
accounting purposes, common stock repurchased under the stock repurchase program is recorded based upon the transaction date of the applicable
trade. Such repurchased shares are held in treasury and are presented using the cost method. These shares are not retired and are considered
issued but not outstanding. There were
Note 15 – At-the-Market Agreement
The
Company previously maintained an Amended and Restated Equity Distribution Agreement (the “Prior ATM Agreement”) with Piper
Sandler & Co. (“Piper Sandler”) and Clear Street, LLC (“Clear Street”), pursuant to which the Company could
offer and sell shares of its common stock having an aggregate offering price of up to $
On
October 20, 2025, the Company entered into a new Equity Distribution Agreement (the “Agreement”) with Maxim Group LLC (“Maxim”)
to establish an at-the-market (“ATM”) equity offering program. Pursuant to the Agreement, the Company may offer and sell
shares of its common stock, par value $
| 53 |
Note 16 – Registered Direct Offerings
On
September 17, 2025, the Company entered into a Securities Purchase Agreement (the “Purchase Agreement”) with two institutional
investors (the “Investors”) named therein, pursuant to which the Company agreed to issue and sell, in a registered direct
offering priced at-the-market under Nasdaq rules by the Company directly to the Investors (the “Offering”) an aggregate of
On
October 28, 2025, the Company entered into a Securities Purchase Agreement (the “Purchase Agreement”) with two institutional
investors (the “Investors”) pursuant to which the Company agreed to issue and sell, in a registered direct offering priced
at-the-market under Nasdaq rules (the “Offering”), (i)
Note 17 – Related Party Transactions
The
Company employs two employees who are related to current or former executive officers. Seth Egan, the Company’s Chief Commercialization
and Strategy Officer, and Winston Egan, the Company’s Director of Customer Experience, are each sons of Dwight Egan, the Company’s
President and Chief Executive Officer and Chairman of the Board. During the year ended December 31, 2025, total compensation paid to
Seth Egan, including salaries, bonuses, and the grant date fair value of equity awards which vest over
Prior
to the acquisition of Advanced Conceptions by the Company in December 2021, the Company’s President, Richard Abbott was serving
as President of Advanced Conception.
In
August 2023, the Company entered into a services agreement with CoSara, the Company’s equity method investment, under which CoSara
provides certain research and development consulting and support services. During the years ended December 31, 2025 and 2024, respectively,
the Company recognized $
Note 18 – Subsequent Events
Reverse Stock Split
On December 5, 2025, the Company’s stockholders approved an amendment to the Company’s Amended and Restated Certificate of Incorporation to effect a reverse stock split (the “Reverse Stock Split”). On December 29, 2025, the Company’s Board of Directors approved a reverse stock split ratio of 1-for-30. The Company filed the amendment with the Secretary of State of the State of Utah, and the Reverse Stock Split became effective on January 1, 2026.
As a result of the Reverse Stock Split, every
The Reverse Stock Split reduced the number of shares
of common stock outstanding from
All share and per-share amounts presented in the accompanying consolidated financial statements, including loss per share, weighted-average shares outstanding, stock-based compensation awards, and warrants, have been retroactively adjusted to reflect the Reverse Stock Split for all periods presented.
Nasdaq Listing Status
Subsequent to December 31, 2025, the Company regained compliance with the minimum bid price requirement under Nasdaq Listing Rule 5550(a)(2). As previously disclosed, the Company’s common stock had been subject to a bid price deficiency and was suspended from trading on The Nasdaq Capital Market effective January 14, 2026.
On March 9, 2026, the Company received written notice
from The Nasdaq Stock Market LLC indicating that it had demonstrated compliance with the $
Nasdaq also notified the Company that it will be
subject to a Discretionary Panel Monitor through March 9, 2027. During this monitoring period, if the Company’s closing bid price
falls below $
Operating Lease Amendment
Subsequent to December 31, 2025, the Company entered into an amendment to its existing operating lease agreement for its corporate headquarters located in Salt Lake City, Utah. The amendment extends the lease term from its original expiration date of February 28, 2026, to December 31, 2028, and includes fixed annual rent escalations consistent with the original agreement. No other material terms of the lease were modified.
Common Stock Sales Under At-the-Market Agreement
Subsequent to December 31, 2025, the Company sold
| 54 |
ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE.
None.
ITEM 9A. CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
We maintain a set of disclosure controls and procedures (as defined in Rule 13a-15(e) of the Exchange Act) designed to ensure that information required to be disclosed in reports filed or submitted under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in rules and forms adopted by the SEC. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the Company’s management, including its principal executive and principal financial officers, as appropriate to allow timely decisions regarding required disclosure.
Our management, with the participation of our Chief Executive Officer and our Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures as of December 31, 2025. Based on the evaluation, management has concluded that our disclosure controls and procedures are effective as of December 31, 2025 to provide reasonable assurance that information required to be disclosed in reports filed or submitted under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms and is accumulated and communicated to management, including our principal executive and principal financial officers, as appropriate to allow timely decisions regarding required disclosure.
Changes in Internal Control Over Financial Reporting
There have not been any changes in the Company’s internal control over financial reporting (as such term is defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) during the fourth quarter of 2025 that have materially affected, or are reasonably likely to materially affect, the Company’s internal control over financial reporting.
Management’s Annual Report on Internal Control over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal control over financial reporting (as defined in Rule 13a-15(f) under the Exchange Act). Our management, including our Chief Executive Officer and Chief Financial Officer, conducted an evaluation of the effectiveness of our internal control over financial reporting as of December 31, 2025. In making its evaluation, management used the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission (COSO) in Internal Control – Integrated Framework (2013).
Based on this evaluation, management determined that our internal control over financial reporting was effective as of December 31, 2025.
This Annual Report does not include an attestation report by our independent registered public accounting firm regarding internal control over financial reporting because we are a non-accelerated filer and therefore are not required to comply with Section 404(b) of the Sarbanes-Oxley Act. Management’s report was not subject to attestation by our registered public accounting firm pursuant to rules of the SEC that permit non-accelerated filers to provide only management’s report in the 10-K.
| 55 |
Inherent Limitations on Effectiveness of Controls
Our management, including our Chief Executive Officer and Chief Financial Officer, believes that our disclosure controls and procedures and internal control over financial reporting are intended to be designed to provide reasonable assurance of achieving their objectives. However, our management does not expect that our disclosure controls and procedures or our internal control over financial reporting will prevent or detect all errors and all fraud. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, have been detected. These inherent limitations include the realities that judgments in decision making can be faulty, and that breakdowns can occur because of a simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people or by management override of the controls. The design of any system of controls also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions; over time, controls may become inadequate because of changes in conditions, or the degree of compliance with policies or procedures may deteriorate. Because of the inherent limitations in a cost–effective control system, misstatements due to error or fraud may occur and not be detected.
ITEM 9B. OTHER INFORMATION
During
the three months ended December 31, 2025, none of our directors or officers
On March 31, 2026, the Company approved and initiated a workforce reduction as part of an ongoing effort to align its cost structure with current business conditions and strategic priorities. The workforce reduction impacts approximately 26% of the Company’s employees across multiple functions. The Company expects that the reduction in force will be substantially completed by April 15, 2026. The Company does not expect to incur material charges in connection with this workforce reduction, as affected employees will receive only compensation through their respective termination dates and payment of accrued obligations in accordance with existing Company policies and applicable law. Accordingly, the Company does not currently anticipate recognizing significant restructuring or severance-related expenses associated with this action. The Company expects that the workforce reduction will result in a reduction of operating expenses beginning in the second quarter of 2026. The Company continues to evaluate its cost structure and may take additional actions as deemed appropriate to support its long-term strategic objectives.
ITEM 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS.
None.
PART III
ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE.
The following table sets forth the names, ages and positions of our executive officers and directors as of March 29, 2026. The following is information on the business experience of each director and executive officer now serving and a discussion of the qualifications, attributes and skills that led to the board of directors’ conclusion that each one is qualified to serve as a director or as an executive officer as the case may be. Executive officers serve at the discretion of the board of directors.
| Name | Age | Position | ||
| Dwight Egan | 72 | Chief Executive Officer, President and Chairman of the Board | ||
| Brian Brown | 50 | Chief Financial Officer and Secretary | ||
| Richard Abbott | 54 | President | ||
| Eugene Durenard | 56 | Director | ||
| James Nelson | 73 | Director | ||
| Richard Serbin | 81 | Director | ||
| Edward Murphy | 61 | Director |
The following is a brief summary of the background of each of our executive officers.
Dwight Egan serves as our Chief Executive Officer and has been an officer and director of the Company since April 2013. Mr. Egan has been engaged in private investment business from February 1999 to the present. He was a senior executive at Data Broadcasting Corporation, a leading provider of wireless, real-time financial market data, news and sophisticated fixed- income portfolio analytics to 27,000 individual and professional investors from 1995 to 1999. He co-founded and served as CEO and Chairman of the Board of Broadcast International, Inc. from 1984 to 1995, when Data Broadcasting Corporation acquired Broadcast International and created CBS MarketWatch, a leading financial news site and participated in its initial public offering. Mr. Egan’s prior experience in executive leadership positions with public companies and working with capital markets qualifies him to serve as our Chairman Chief Executive Officer.
Brian Brown became our Chief Financial Officer in February 2021. From July 2020 until February 2021, Mr. Brown served as the Chief Financial Officer of A-Core Concrete Cutting, Inc. where his duties included overseeing the company’s accounting and finance departments, mergers and acquisitions and responsibility for financial forecasting and budgeting. From January 2020 to July 2020, Mr. Brown was an independent consultant. From August 2019 to December 2019, Mr. Brown served as the Vice President of Accounting, Treasury and Investor Relations at Sportsman’s Warehouse Holdings, Inc., a public company reporting on Nasdaq Global Select under the symbol SPWH, where his duties included overseeing the company’s accounting, treasury and investor relations departments, preparing the company’s annual, quarterly and current reports with the SEC, overseeing all aspects of the company’s annual audit, including, but not limited to, the preparation and review of audit support schedules, preparation of financial statements and footnotes, and providing support to the company’s independent auditors. From October 2009 to August 2019, Mr. Brown served as the Director of Finance of Sportsman’s Warehouse Holdings, Inc. where he assisted with the company’s initial public offering in April 2014 as well as effecting private and secondary public offerings, acquisitions of a group of retail stores and preparing the company’s periodic and current reports with the SEC and complying with the Sarbanes Oxley Act. From May 2005 to October 2009, Mr. Brown served as the Corporate Controller of Franklin Covey Products where he developed and maintained the company’s internal controls over financial reporting structure in accordance with the control standards required under Section 404 of the Sarbanes Oxley Act. From July 2001 to May 2005, Mr. Brown served as an Assurance Senior at KPMG, LLP where he provided audit services to various clients in multiple industries. Mr. Brown holds a Bachelor of Arts in Accounting and Masters of Professional Accountancy from the University of Utah. Mr. Brown is a licensed CPA in Utah.
Richard Abbott has served as President of Co-Diagnostics since March 2024. Prior to being appointed as President, from January 2021 to March 2024, Mr. Abbott served as President of Advanced Conceptions, Inc., a privately held medical device company focused on the design of automated instruments that solve challenging cross-disciplinary problems. Advanced Conceptions is a wholly owned subsidiary of Co-Diagnostics, Inc. From September 2018 to January 2021, Mr. Abbott was a partner in SaltRidge, LLC through which he provided management services to Advanced Conceptions and other consulting services. From August 2017 to August 2018, he served as the Chief Technology Officer for privately held Vilicus, a cloud centered network provider of IoT devices for indoor agriculture. From October 2016 to July 2017, Mr. Abbott served as the Chief Technology Officer for Fenome, a private company focused on the manipulation of phenotypic expression of indoor agriculture crops via environmental control during growth and fruiting. Mr. Abbott holds a Master of Business Administration from The Wharton School and a Master of Science, Mechanical Engineering and a Bachelors Mechanical Engineering from Brigham Young University.
| 56 |
The following is a brief summary of the background of each of our directors:
Eugene Durenard has been a member of our board of directors since June 2019. Dr. Durenard is the Founder and CEO of Hyperbolic Holdings, a Swiss-based holding, management consulting and strategy advisory company specialized in healthcare. For the last 7 years he has been working with family offices on direct investments and philanthropy focused on life sciences. He serves on the advisory board of several private companies in the biotech and MedTech sectors. After an initial career in proprietary research and trading at Salomon Brothers and Credit Suisse in London, he co-founded Orion Investment Management in Bermuda specializing in quantitative asset and liability management for institutions and private clients. He subsequently sold it to Capital G Bank and co-headed their asset management. Dr. Durenard spent several years establishing personal connections with representatives of 40+ clusters of life science innovation, families operating healthcare businesses and industry leaders globally. He regularly visits labs and incubators, meets with leading scientists and innovators in order to keep abreast of current trends and developments. His advice is based on a thorough analysis that combines in-depth knowledge of science, competitive forces and financial expertise. He has published several articles in asset-liability management industry magazines as well as the book “Professional Automated Trading — Theory and Practice” (Wiley 2013). He has a PhD in Mathematics from Harvard University. Dr. Durenard brings a thorough multi-asset class investment and entrepreneurial experience spanning 25 years to the Company’s board of directors. We believe that Mr. Durenard’s knowledge of accounting and finance and his extensive experience in the life science industry greatly benefits the Board.
James Nelson has been a member of our board of directors since June 2019. Mr. Nelson is the retired Chairman and CEO of Sunworks, Inc., a NASDAQ traded commercial, agriculture, and residential solar Integrator which he helped found in October 2010. Mr. Nelson spent most of his career working in private equity as a general partner with Peterson Partners and with Millennial Capital Partners. In addition to his investment and financial responsibilities, he served as CEO of two of his firms’ portfolio companies. Prior to his years in private equity, Mr. Nelson served as Vice President of Marketing at Banana Republic, where he managed company-wide marketing, as well as the company’s international expansion initiative. He was also general manager for Banana Republic’s catalog division. He was Vice President of Marketing and Corporate Development at Saga Corporation, a multi-billion-dollar food service company. Mr. Nelson began his executive career over 35 years ago at Bain and Company, a business strategy consulting firm, where he managed teams of consultants on four continents. Mr. Nelson received his MBA from Brigham Young University, where he graduated summa cum laude and was named the Outstanding Master of Business Administration Graduate. Mr. Nelson’s advice to the board of directors from his experiences as a chief executive officer, strategic advisor and knowledge of capital markets greatly benefits our Board of Directors.
Richard Serbin has been a member of our board of directors since May 2017. Mr. Serbin currently serves as a consultant to many companies in the healthcare industry. Since January 2024, he has served as Chairman of the Board of Directors of Platform Pharmaceuticals. He was the President of Corporate Development and In-House Legal Counsel at Life Science Institute, LLC, from June 1, 2013 to July 15, 2014. He served as Director at Viropro Inc. from May 2013 to June 2014. He was Head of Business Advisory Board at Mazal Plant Pharmaceuticals Inc. from October 2006 to September 2007 and also served as its Member of Business Advisory Board. He served as Chief Executive Officer of Optigenex Inc. from July 2002 to September 15, 2005 and a director from July 2004 to September 2005. From January 1999 until July 2002 Mr. Serbin served as a consultant to various pharmaceutical companies. He served as the President of Bradley Pharmaceuticals. He served as Vice President of Corporate Development at Ortho Pharmaceuticals, a Johnson & Johnson subsidiary, and practiced Patent and FDA law at Revlon Johnson & Johnson and Schering-Plough. He served as Patent Attorney for Schering Plough Corporation and Chief FDA Counsel for Revlon Corporation and Johnson and Johnson Corporation. Subsequently, he worked at Revlon Corporation, as its Chief Food, Drug and Cosmetic Counsel. He founded Radius Scientific Corporation. He was J&J’s Vice President of Corporate Development, and later led a successful public offering venture based on technology developed at Stanford Medical School. Mr. Serbin spent a large portion of his career focusing on international markets and clients. While at J&J, Mr. Serbin served on the board of directors of 16 US and international subsidiary companies, including Ethicon, Ortho, J&J Consumer Products, Pittman-Moore, Mc Neil, and J&J Development Corporation. He worked on multiple international acquisitions and strategic relationships, and sat on the board of directors of several of its international subsidiaries, including those in India, Hong Kong, Japan, Taiwan, Germany, and England. Mr. Serbin has a B.S. and a B. Pharmacy from Rutgers University and Rutgers University College of Pharmacy, a J.D. degree from Seton Hall Law School and a Master’s Degree in Trade Regulations and Law from NYU Law School. Mr. Serbin’s experience in business, law and medicine and knowledge gained as an advisor to the healthcare industry greatly benefits our Board of Directors, and is critical to our board of directors as we continue to commercialize our products.
Edward Murphy has been a member of our board of directors since June 2019. Since December 1999, Mr. Murphy has served as a senior vice president and a partner of Dover Investments Ltd., a private investment firm. Throughout his career, Mr. Murphy’s duties have included investment analysis of various types of investment projects in real estate and financial services. Currently, Mr. Murphy serves on the board of directors of several Canadian and American publicly reporting companies that have interests in various industries. He has been a Director at Empire Minerals Corporation Inc. since January 2016, at the Mosport Park Entertainment Corporation from April 30, 1997 until it became Digicrypts Blockchain Solutions Inc. in June 2011 until he resigned in November 2022, at Lakefield Marketing Corporation since February 2018, CEO/CFO and Director of Credo Resources Inc. since September 2019, and at Essex Oil Ltd. since July 2021, and at Darkhorse Technologies Ltd. since November 2021. He served as a Director at Aurquest Resources from May 2003 to December 2017. He has also served as Director at E Ventures Inc. since April 2023. Mr. Murphy’s experience in the capital markets and his involvement in investment analysis greatly benefits our Board of Directors.
Dwight Egan – See narrative description above.
| 57 |
Involvement in Certain Legal Proceedings
To the best of our knowledge, none of our directors or executive officers has been involved in any bankruptcy or criminal proceedings (other than traffic and other minor offenses) or been subject to any of the items set forth under Item 401(f) of Regulation S-K, nor have there been any judgments or injunctions brought against any of our directors or executive officers during the last ten years that we consider material to the evaluation of the ability and integrity of any director or executive officer.
Board and Committee Matters
Our board of directors has five members. The Chairman of the Board and our Chief Executive Officer, Dwight Egan, is a member of the board and is a full-time employee of the Company. Eugene Durenard, Edward Murphy, James Nelson and Richard Serbin are non-employee directors, and the board has determined that these persons (who constitute a majority of the board) are “independent directors” under the criteria set forth in Rule 5605(a)(2) of the Nasdaq Listing Rules. The board met eleven times during the year ended December 31, 2025. All directors attended more than seventy-five percent (75%) of the meetings of the board and committee meetings of which such director was a member held during 2025.
We maintain an audit committee of the board, a compensation committee of the board, a corporate governance committee of the board and a nominating committee of the board, each of which is discussed below. Our board of directors may from time to time establish other standing committees. In addition, from time to time, special committees may be established under the direction of our board of directors when necessary to address specific issues.
The following table sets forth a description of the four permanent board committees and the chairpersons and members of those committees, all of whom are independent directors:
| Committee | Independent Chairperson | Independent Members | ||||||
| Audit Committee | Eugene Durenard | Edward Murphy | James Nelson | Richard S. Serbin | ||||
| Compensation Committee | Richard S. Serbin | Edward Murphy | Eugene Durenard | James Nelson | ||||
| Governance Committee | James Nelson | Edward Murphy | Eugene Durenard | Richard S. Serbin | ||||
| Nominating Committee | Edward Murphy | James Nelson | Eugene Durenard | Richard S. Serbin | ||||
Audit Committee and Financial Expert
Our audit committee currently is comprised of Messrs. Durenard, Nelson, Murphy and Serbin with Mr. Durenard serving as chairperson of the audit committee. The functions of the audit committee include engaging an independent registered public accounting firm to audit our annual financial statements, reviewing the independence of our auditors, the financial statements and the auditors’ report, and reviewing management’s administration of our system of internal control over financial reporting and disclosure controls and procedures. The board of directors has adopted a written audit committee charter. A current copy of the audit committee charter is available to security holders on our website at www.codiagnostics.com. Our board has determined that all our directors that are serving on the audit committee are “independent” under the definition of independence in the Marketplace rules of the NASDAQ listing standards. The Audit Committee met four times during the year ended December 31, 2025. All committee members attended more than seventy-five percent (75%) of the meetings of the Audit Committee held during 2025.
Our board of directors has determined that Mr. Durenard meets the requirements of an “audit committee financial expert” as defined in applicable SEC regulations.
| 58 |
Compensation Committee
Our compensation committee currently includes Messrs. Serbin, Nelson, Murphy and Durenard with Mr. Serbin serving as chairperson of the compensation committee. The functions of the compensation committee include reviewing and approving corporate goals relevant to compensation for executive officers, evaluating the effectiveness of our compensation practices, evaluating and approving the compensation of our chief executive officer and other executives, recommending compensation for board members, and reviewing and making recommendations regarding incentive compensation and other employee benefit plans. The board of directors has adopted a written compensation committee charter. A current copy of the compensation committee charter is available to shareholders on our website at www.codiagnostics.com. Our board has determined that all of our directors serving on the compensation committee are “independent” under the definition of independence in the Marketplace Rules of the NASDAQ listing standards. The Compensation Committee did not meet as a separate committee in 2025, but rather, because the committee is comprised of all four independent directors, committee matters were addressed as necessary in meetings of the board for the year ended December 31, 2025.
Corporate Governance Committee
Our Corporate Governance Committee currently includes Messrs. Nelson, Murphy, Durenard and Serbin with Mr. Nelson serving as chairperson of the Corporate Governance Committee. Among other items, the committee is tasked by the board of directors to develop and recommend to the board the Corporate Governance Guidelines of the Company and oversee compliance therewith. A current copy of the Corporate Governance committee charter is available to shareholders on our website at www.codiagnostics.com. Our board has determined all directors serving on the Corporate Governance committee are “independent” under the definition of independence in the Marketplace Rules of the NASDAQ listing standards. The Corporate Governance Committee did not meet as a separate committee in 2025, but rather, because the committee is comprised of all four independent directors, committee matters were addressed as necessary in meetings of the board for the year ended December 31, 2025.
Nominating Committee
Our Nominating Committee was split from the Corporate Governance Committee in 2022 and currently includes Messrs. Nelson, Murphy, Durenard and Serbin with Mr. Murphy serving as chairperson of the Nominating Committee. The Nominating Committee has been established by the board, among other things to: assist the board in effecting board organization, membership and function including identifying qualified board nominees; assist the board in effecting the organization, membership and function of board committees including the composition of board committees and recommending qualified candidates therefor; evaluate and provide successor planning for the Chief Executive Officer and other executive officers; and develop criteria for board membership, such as independence, term limits, age limits and ability of former employees to serve on the board and the evaluation of candidates’ qualifications for nominations to the board and its committees as well as removal therefrom. The Nominating Committee did not meet as a separate committee in 2025, but rather, because the committee is comprised of all four independent directors, committee matters were addressed as necessary in meetings of the board for the year ended December 31, 2025.
Board Nominations
In considering board candidates, the board seeks individuals of proven judgment and competence who have strong reputations in their respective fields. Although we do not have a formal diversity policy, the board considers such factors as experience, education, employment history, special talents or personal attributes, anticipated participation in board activities, and geographic and diversity factors. The process for identifying and evaluating nominees would include detailed consideration of the recommendations and opinions of members of our board, our executive officers, and our stockholders. There would be no difference in the process of evaluation of candidates recommended by a stockholder and those recommended by other sources.
| 59 |
Our Amended and Restated Bylaws (the “Bylaws”) set forth procedures for shareholders to recommend nominees to the Company’s board. Nominations of persons for election to the board of directors to be considered by the stockholders may be made at an annual meeting of stockholders (i) pursuant to the Company’s notice of meeting, (ii) by or at the direction of the board of directors, or (iii) by any stockholder of the Company who (A) was a stockholder of record at the time of giving of the notice, (B) is entitled to vote with respect to such matter at the meeting, and (C) complies with the notice procedures set forth in the Bylaws.
The following is a summary of key provisions from our Bylaws. For nominations to be properly brought before an annual meeting by a stockholder, the stockholder making such nominations must have given timely notice in writing to the secretary of the Company. To be timely, a stockholder’s notice shall be delivered to the secretary at the principal executive offices of the Company not later than the close of business on the 75th day nor earlier than the close of business on the 125th day prior to the first anniversary of the preceding year’s annual meeting; provided, however, that in the event that the date of the annual meeting is more than 30 days before or more than 60 days after such anniversary date, notice by the stockholder to be timely must be so delivered not later than the close of business on the later of (x) the 75th day prior to the scheduled date of such annual meeting or (y) the 15th day following the day on which public announcement of the date of such meeting is first made by the Company. To be in proper form, a stockholder’s notice to the secretary must: set forth, as to the stockholder giving the notice and the beneficial owner, if any, on whose behalf the nomination or proposal is made (A) the name and address of such stockholder, as they appear on the Company’s books, and of such beneficial owner, if any, (B) the class or series and number of shares of the Company that are, directly or indirectly, owned beneficially and of record by such stockholder and such beneficial owner, if any, as of the date of such notice, and (C) any other information relating to such stockholder and beneficial owner, if any, that would be required to be disclosed in a proxy statement or other filings required to be made in connection with solicitations of proxies for, as applicable, the proposal and/or for the election of directors in a contested election pursuant to Section 14 of the Securities Exchange Act of 1934, as amended, and the rules and regulations promulgated thereunder (the “Exchange Act”). In addition, shareholders who intend to solicit proxies in support of director nominees other than the company’s nominees must also comply with the additional requirements of Rule 14a-19(b).
The notice shall set forth, as to each person, if any, whom the stockholder proposes to nominate for election or reelection as a director (A) all information relating to such person that would be required to be disclosed in a proxy statement or other filings required to be made in connection with solicitations of proxies for election of directors in a contested election pursuant to Section 14 of the Exchange Act (including such person’s written consent to being named in the proxy statement as a nominee and to serving as a director if elected) and (B) a description of all direct and indirect compensation and other monetary agreements, arrangements and understandings during the past three years, and any other relationships, between or among such stockholder and beneficial owner, if any, and their respective affiliates and associates, or others acting in concert therewith, on the one hand, and each proposed nominee, and his or her respective affiliates and associates, or others acting in concert therewith, on the other hand, including, without limitation all information that would be required to be disclosed pursuant to Rule 404 promulgated under Regulation S-K if the stockholder making the nomination and any beneficial owner on whose behalf the nomination is made, if any, or any affiliate or associate thereof or person acting in concert therewith, were the “registrant” for purposes of such rule and the nominee were a director or executive officer of such registrant; and with respect to each nominee for election or reelection to the board of directors, include the completed and signed questionnaire, representation, and agreement required by the Bylaws. The Company may require any proposed nominee to furnish such other information as may reasonably be required by the Company to determine the eligibility of such proposed nominee to serve as an independent director of the Company or that could be material to a reasonable stockholder’s understanding of the independence, or lack thereof, of such nominee.
Communication with the Board
We have not, to date, developed a formal process for shareholder communications with the board of directors. We believe our current informal process, in which any communication sent to the board of directors, either generally or in care of the chief executive officer, secretary or other corporate officer or director, is forwarded to all members of the board of directors, has served the board’s and the shareholders’ needs.
Conflicts of Interests
On an annual basis, each director and executive officer is obligated to complete a director and officer questionnaire that requires disclosure of any transactions with our company, including related person transactions reportable under SEC rules, in which the director or executive officer, or any member of his or her immediate family, have a direct or indirect material interest. Under our company’s standards of conduct for employees, all employees, including the executive officers, are expected to avoid conflicts of interest. Pursuant to our code of ethics for the chief executive officer and senior finance officers (as discussed below), such officers are prohibited from engaging in any conflict of interest unless a specific exception has been granted by the board. All of our directors are subject to general fiduciary standards to act in the best interests of our company and our shareholders. Conflicts of interest involving an executive officer or a director are generally resolved by the board.
| 60 |
Role of the Board in Risk Oversight
Risk is inherent with every business, and how well a business manages risk can ultimately determine its success. Management is responsible for the day-to-day management of the risks that we face, while our board of directors, as a whole and through its committees, has responsibility for the oversight of risk management. In its risk oversight role, our board of directors is responsible for satisfying itself that the risk management processes designed and implemented by management are adequate and functioning as designed.
Our board of directors does not have a standing risk management committee, but rather administers this oversight function directly through our board of directors as a whole, as well as through various standing committees of the board of directors that address risks inherent in their respective areas of oversight. In particular, our board of directors is responsible for monitoring and assessing strategic risk exposure, including a determination of the nature and level of risk appropriate for us. Our Audit Committee has the responsibility to consider and discuss our major financial risk exposures and the steps our management has taken to monitor and control these exposures, including guidelines and policies to govern the process by which risk assessment and management is undertaken. The Audit Committee also monitors oversight of the performance of our internal audit function. Our Corporate Governance Committee monitors the effectiveness of our corporate governance guidelines, including whether they are successful in preventing illegal or improper liability-creating conduct. Our Compensation Committee assesses and monitors whether any of our compensation policies and programs have the potential to encourage excessive risk-taking or promote behaviors contra to our Code of Business Conduct. Our Nominating Committee assesses and monitors the effectiveness of the board and its committees and evaluates board members and nominees for election to the board and succession planning for the CEO and other executive officers.
Code of Ethics
We have adopted a code of ethics for our principal executive officer, principal financial officer, controller, or persons performing similar functions. A copy of the code of ethics is included on our website at www.codiagnostics.com.
Insider Trading Policy
We
have
Family Relationships
There are no family relationships among our directors and executive officers.
ITEM 11. EXECUTIVE COMPENSATION
We are a “smaller reporting company” as defined in the rules and regulations of the SEC. As a smaller reporting company, we may take advantage of specified reduced disclosure and other requirements that are otherwise applicable, in general, to public companies that are not smaller reporting companies. Accordingly, this Report includes reduced disclosure about our executive compensation arrangements.
Summary Compensation Table
The table below summarizes the total compensation paid or earned by each of the named executive officers in their respective capacities for the fiscal years ended December 31, 2025 and 2024. We have omitted in this report certain columns otherwise required to be included because there was no compensation made with respect to such columns, as permitted by applicable SEC regulations.
| Name and Principal Position | Year | Salary | Bonus | Stock Awards (1) | All Other Comp | Total Compensation | |||||||||||||||||
| Dwight Egan President & Chief Executive Officer | 2025 | $ | 400,000 | $ | 60,000 | $ | 68,750 | $ | - | $ | 528,750 | ||||||||||||
| 2024 | $ | 391,667 | $ | 20,000 | $ | 305,250 | $ | - | $ | 716,917 | |||||||||||||
| Brian Brown Chief Financial Officer and Secretary | 2025 | $ | 320,000 | $ | 45,000 | $ | 56,250 | $ | - | $ | 421,250 | ||||||||||||
| 2024 | $ | 313,333 | $ | 15,000 | $ | 249,750 | $ | - | $ | 578,083 | |||||||||||||
| Richard Abbott President | 2025 | $ | 290,000 | $ | 15,000 | $ | 55,000 | $ | - | $ | 360,000 | ||||||||||||
| 2024 | $ | 276,666 | $ | 15,000 | $ | 133,200 | $ | - | $ | 424,866 | |||||||||||||
| (1) | The amounts reported in this column represent the aggregate grant date fair value of the restricted stock units, or RSUs, granted under our 2015 Plan as computed in accordance with FASB ASC Topic 718. Note that the amounts reported in this column reflect the accounting value for these equity awards and do not correspond to the actual economic value that may be received from the equity awards as the RSUs vest over three years. |
Narrative Disclosure to Summary Compensation Table: We do not have written employment agreements with any of our executive officers. All of our executive officers serve on an at-will basis. The base salaries for our named executive officers were determined by our compensation committee after reviewing a number of factors, including: the responsibilities associated with the position, the seniority of the executive’s position, the base salary level in prior years, and our financial position; and for executive officers other than our Chief Executive Officer, recommendations made by our Chief Executive Officer. By utilizing a combination of objective and subjective performance factors critical to our success, the board will award cash bonuses intended to incentivize our executive officers to achieve results that benefit them and the Company. Performance factors include the achievement of predetermined financial performance objectives, adherence to financial discipline measures and achievement of business development, product development and long-term business stability. The board may modify or re-weight the objectives during the course of the fiscal year, if necessary, to reflect changes in our business plan.
| 61 |
Outstanding Equity Awards at Fiscal Year-End 2025
The following table contains certain information concerning outstanding equity awards for the Named Executive Officers as of December 31, 2025.
| Option Awards | Stock Awards | |||||||||||||||||||||||||||||||
| Number of Securities Underlying Unexercised Options (#) | Option Exercise | Option Expiration | Number of Shares or Units of Stock That Have Not Vested | Market Value of Shares or Units of Stock That Have Not Vested | Number of Unearned Shares, Units or Other Rights That Have Not Vested | Market or Payout Value of Unearned Shares, Units or Other Rights That Have Not Vested | ||||||||||||||||||||||||||
| Name | Exercisable | Unexercisable | Price | Date | (#) | ($) (1) | (#) | ($) | ||||||||||||||||||||||||
| Dwight Egan | 1,667 | - | $ | 78.90 | 09/20/28 | - | - | - | - | |||||||||||||||||||||||
| 1,667 | - | $ | 33.00 | 09/02/29 | - | - | - | - | ||||||||||||||||||||||||
| - | - | - | - | 1,528 | (4) | $ | 260 | - | - | |||||||||||||||||||||||
| - | - | - | - | 4,583 | (5) | $ | 779 | - | - | |||||||||||||||||||||||
| - | - | - | - | 7,639 | (6) | $ | 1,299 | - | - | |||||||||||||||||||||||
| Brian Brown | - | - | - | - | 1,250 | (4) | $ | 213 | - | - | ||||||||||||||||||||||
| - | - | - | - | 3,750 | (5) | $ | 638 | - | - | |||||||||||||||||||||||
| - | - | - | - | 6,250 | (6) | $ | 1,063 | - | - | |||||||||||||||||||||||
| Richard Abbott | - | - | - | - | 1,098 | (2) | $ | 187 | - | - | ||||||||||||||||||||||
| - | - | - | - | 584 | (3) | $ | 99 | - | - | |||||||||||||||||||||||
| - | - | - | - | 2,000 | (5) | $ | 340 | - | - | |||||||||||||||||||||||
| - | - | - | - | 6,111 | (6) | $ | 1,039 | - | - | |||||||||||||||||||||||
(1) Based on $5.10 per share, which was the closing price of our common stock on December 31, 2025.
(2) Consists of restricted stock units granted on 7/25/2022, which vest in 6 installments commencing six months after the achievement of certain specified milestones and continuing every six months thereafter.
(3) Consists of restricted stock units granted on 1/17/2023, which vest in 6 installments commencing six months after the achievement of certain specified milestones and continuing every six months thereafter.
(4) Consists of restricted stock units granted on 5/15/2023, which vest in 6 installments commencing on 11/23/2023 and continuing every six months thereafter.
(5) Consists of restricted stock units granted on 4/26/2024, which vest in 6 installments commencing on 11/23/2024 and continuing every six months thereafter.
(6) Consists of restricted stock units granted on 8/11/2025, which vest in 6 installments commencing on 11/23/2025 and continuing every six months thereafter.
Potential Payments Upon Termination or Change of Control
At the recommendation of the compensation committee of the board of directors, the Board approved the Co-Diagnostics, Inc. Change in Control Severance Plan (the “Plan”). The Plan provides severance benefits to a select group of designated management or highly compensated participants in the event their employment or affiliation with the Company or an affiliate is terminated due to a change in control (as defined in the Plan). Participants entitled to benefits under the Plan are designated from time-to-time by the Compensation Committee pursuant to the terms of an “Award Notice,” the form of which is appended to the Plan. The Award Notice identifies the eligible participant and the Severance Multiplier (as defined in the Plan) to which the participant is entitled. The Compensation Committee approved participation in the Plan for certain executives of the Company, including the Company’s CEO, Dwight Egan, with a Severance Multiplier of three times his severance benefit and the Company’s CFO, Brian Brown, with a Severance Multiplier of two times his severance benefit.
Under the Plan, if a participant’s employment or affiliation is terminated without “cause” or by the participant for “good reason” (each, as defined in the Plan) during the two-year period following a change in control, a participant will be entitled to a severance benefit equal to the participant’s Severance Multiplier as set forth in the participant’s Award Notice, times the sum of: (i) the participant’s annual base salary; and (ii) the greater of the participant’s target bonus or the average of the three highest actual annual cash bonuses paid to participant over the five preceding completed years.
The participant’s receipt of any of the payments or benefits is subject to the participant’s delivery to the Company of a separation agreement of the type that are ordinarily entered into in similar situations, in a form acceptable to the Company, in its sole discretion, which separation agreement may include a requirement for the participant to remain in the employ or service of the Company for a reasonable period of time after completion of the Change in Control transaction to assist in any transition activities for which participant’s services would be required.
| 62 |
Director Compensation
We use a combination of cash and stock-based incentive compensation to attract and retain qualified candidates to serve on its board of directors. In setting director compensation, we consider the significant amount of time that directors expend in fulfilling their duties as well as the skill level required by our members of the board.
The table below summarizes the compensation paid or accrued by us to each of our non-employee directors for the fiscal year ended December 31, 2025.
| Name | Fees
Earned or Paid in Cash | Stock
Awards: Value of Restricted Stock Units (1) | Total | |||||||||
| Richard Serbin (2) | $ | 106,500 | $ | 31,250 | $ | 137,750 | ||||||
| James Nelson (3) | $ | 106,500 | $ | 31,250 | $ | 137,750 | ||||||
| Edward Murphy (4) | $ | 106,500 | $ | 31,250 | $ | 137,750 | ||||||
| Eugene Durenard (5) | $ | 109,500 | $ | 31,250 | $ | 140,750 | ||||||
| (1) | The amounts reported in this column represent the aggregate grant date fair value of the restricted stock units, or RSUs, granted under our 2015 Plan as computed in accordance with FASB ASC Topic 718. Note that the amounts reported in this column reflect the accounting value for these equity awards and do not correspond to the actual economic value that may be received from the equity awards. The RSUs vested immediately upon grant. |
| (2) | As of December 31, 2025, Mr. Serbin had 5,694 RSU awards outstanding. |
| (3) | As of December 31, 2025, Mr. Nelson had 5,694 RSU awards outstanding. |
| (4) | As of December 31, 2025, Mr. Murphy had 5,694 RSU awards outstanding. |
| (5) | As of December 31, 2025, Mr. Durenard had 5,694 RSU awards outstanding. |
Our non-employee directors receive cash compensation of $100,000 per year, paid quarterly. In 2024, they also received 3,667 RSU’s vesting 1/6th equally in November 2024, 2025, and 2026 and May 2025, 2026, and 2027. In 2025, they received 4,167 RSU’s vesting 1/6th equally in November 2025, 2026, and 2027 and May 2026, 2027, and 2028. In addition, non-employee directors may be entitled to receive special awards of stock options or RSUs from time to time as determined by the board. The chairman of the board and the chairperson of each of the audit, corporate governance, nomination, and compensation committees receive no additional fees for serving in such capacities. There is no additional compensation for meeting attendance. Directors who are employees of the Company receive no additional compensation for serving as directors. All stock options granted to outside directors are immediately exercisable and expire ten years from the date of grant or 30 days after the date they cease to be directors. Directors are reimbursed for ordinary expenses incurred in connection with attending board and committee meetings.
Equity Incentive Plans
Under our Amended and Restated 2015 Long-term Incentive Plan (the “2015 Plan”) and our 2025 Equity Incentive Plan (the “2025 Plan”), the board of directors may issue incentive stock-based awards to employees, directors and consultants of the company. Options awarded generally expire ten years after being granted. Any stock-based awards granted vest in accordance with the vesting schedule determined by the board of directors. Should an employee’s director’s or consultant’s relationship with the company terminate before the vesting period is completed, the unvested portion of each grant is forfeited. We maintain and grant awards under the 2025 Plan and continue to maintain previously granted awards under the 2015 Plan, which will remain in effect until their expirations by their terms.
The purpose of our incentive plans is to advance the interests of our stockholders by enhancing our ability to attract, retain and motivate persons who are expected to make important contributions to the company by providing them with both equity ownership opportunities and performance-based incentives intended to align their interests with those of our stockholders. These plans are designed to provide us with flexibility to select from among various equity-based compensation methods, and to be able to address changing accounting and tax rules and corporate governance practices by optimally utilizing stock-based awards.
| 63 |
ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS
The following table sets forth certain information, as of March 29, 2026, with respect to the holdings of (1) each person who is the beneficial owner of more than 5% of our Common Stock, (2) each of our directors, (3) each named executive officer, and (4) all of our current directors and executive officers as a group.
Beneficial ownership of the common stock is determined in accordance with the rules of the Securities and Exchange Commission and includes any shares of common stock over which a person exercises sole or shared voting or investment power, or of which a person has a right to acquire ownership at any time within 60 days of March 29, 2026. Applicable percentage ownership in the following table is based on 3,602,465 shares of common stock, after the effects of the January 2026 reverse stock split, plus, for each individual, any securities that individual has the right to acquire within 60 days of March 29, 2026.
The information in the table below is based on information known to us or ascertained by us from public filings made by the stockholders. Except as otherwise indicated in the table below, addresses of the director, executive officers and named beneficial owners are in care of Co-Diagnostics, Inc., 2401 S. Foothill Drive, Suite D, Salt Lake City, Utah 84109.
| Number of Shares Beneficially Owned | Percentage of Class (1) | |||||||
| Named Executive Officers and Directors | ||||||||
| Dwight Egan (1) | 32,860 | * | ||||||
| Brian Brown | 23,729 | * |
||||||
| Richard Abbott | 23,791 | * |
||||||
| Edward Murphy (2) | 12,751 | * | ||||||
| Eugene Durenard | 10,668 | * | ||||||
| James Nelson (3) | 12,335 | * | ||||||
| Richard Serbin (4) | 11,433 | * | ||||||
| All Directors and Executive Officers as a Group (7 persons) | 127,567 | 3.5 | % | |||||
*Represents beneficial ownership of less than 1%.
| (1) | Includes exercisable options to acquire 3,334 shares of common stock. |
| (2) | Includes exercisable options to acquire 1,667 shares of common stock. |
| (3) | Includes exercisable options to acquire 1,667 shares of common stock. |
| (4) | Includes exercisable options to acquire 682 shares of common stock. |
Equity Compensation Plan Information
| Plan Category | (a) Number of Shares to be Issued upon Exercise of Outstanding Options and Rights | (b) Weighted-average Exercise Price of Outstanding Options and Rights | (c) Number of Securities Remaining Available for Future Issuance Under Equity Compensation Plans (Excluding Securities Referenced in Column (a)) | |||||||||
| Equity compensation plans approved by stockholders | 145,628 | (1) | $ | 68.91 | (2) | 246,933 | ||||||
| Equity compensation plans not approved by stockholders | - | $ | - | - | ||||||||
| Total | 145,628 | (1) | $ | 68.91 | (2) | 246,933 | ||||||
| (1) | Includes options and restricted stock units outstanding under our 2015 and 2025 Equity Incentive Plans. |
| (2) | Represents weighted-average exercise price per share of common stock acquirable upon exercise of outstanding stock options. |
| 64 |
ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE
The Company employs two employees who are related to current or former executive officers. Seth Egan, the Company’s Chief Commercialization and Strategy Officer, and Winston Egan, the Company’s Director of Customer Experience, are each sons of Dwight Egan, the Company’s President and Chief Executive Officer and Chairman of the Board. During the year ended December 31, 2025, total compensation paid to Seth Egan, including salaries, bonuses, and the grant date fair value of equity awards which vest over three years, was $0.4 million, and total compensation paid to Winston Egan, including salaries, bonuses, and the grant date fair value of equity awards which vest over three years, was $0.2 million.
Prior to the acquisition of Advanced Conceptions by the Company in December 2021, the Company’s President, Richard Abbott was serving as President of Advanced Conception. At the time of the acquisition, Mr. Abbott was an indirect shareholder of Advanced Conceptions, Inc. through his fifty percent (50%) ownership interest in Whiteknob LLC. Whiteknob LLC owned 71.61% of Advanced Conceptions at the time of the acquisition. The terms of the acquisition agreement between the Company and Advanced Conceptions include the opportunity for Whiteknob LLC to earn an additional 16,913 common shares and an additional 5,551 common stock purchase warrants of Co-Diagnostics upon the achievement of certain milestones. Should those milestone events be achieved Mr. Abbott would have a fifty percent (50%) interest in the common shares and common stock purchase warrants.
Policy for Review of Related Party Transactions
The review of transactions with related persons policy is set forth in our Corporate Governance Committee Charter. The Corporate Governance Committee is to oversee the administration of any related party transactions policy in effect with respect to transactions in which the Company is a participant and involving directors, nominees for director, executive officers of the Company or holders of more than 5% of the Company’s common stock or immediate family members of any such person.
Director Independence
For information regarding the independence of our directors, see “Directors, Executive Officers and Corporate Governance” in Part III, Item 10 of this Form 10-K.
ITEM 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES
The aggregate fees and expenses for professional services rendered by our principal accounting firm, Tanner LLC, for the years ended December 31, 2025 and 2024, respectively, are as follows:
| Years Ended December 31, | ||||||||
| 2025 | 2024 | |||||||
| Audit fees | $ | 180,309 | $ | 176,078 | ||||
| Audit related fees | 359,601 | 18,845 | ||||||
| Total fees | $ | 539,910 | $ | 194,923 | ||||
Audit fees relate to professional services provided in connection with the audit of our annual consolidated financial statements and reviews of our quarterly consolidated financial statements. Audit related fees relate to audits of the financial statements of Cosara, audits of the financial statements of our benefit plans, and professional services related to our equity financing transactions.
The audit committee has adopted a policy that requires advance approval of all services performed by the independent auditor when fees are expected to exceed $15,000. The audit committee has delegated to the audit committee chairperson, Mr. Durenard, the authority to approve services, subject to ratification by the audit committee at its next committee meeting. All fees incurred were pre-approved by the audit committee.
| 65 |
PART IV
Item 15. Exhibits and Financial Statement Schedules.
| (a) | The following documents are filed as part of this Annual Report on Form 10-K: |
| (1) | Financial Statements. The Consolidated Financial Statements filed as part of this Annual Report on Form 10-K are included in Part II, Item 8 of this Annual Report on Form 10-K. | |
| (2) | Financial statement schedules. There are no financial statements schedules included because they are either not applicable or the required information is shown in the consolidated financial statements or the notes thereto. | |
| (3) | Exhibits. The exhibits required by Item 601 of Regulation S-K and Item 15(b) of this Annual Report are listed in the Exhibit Index below. The exhibits listed in the Exhibit Index are incorporated by reference herein. |
Exhibit Number |
Exhibit Description | Filed with this Report |
Incorporated by Reference herein from Form or Schedule |
Filing Date |
SEC File/Reg. Number | |||||
| 2.1*+ | Agreement and Plan of Merger by and between Co-Diagnostics, Inc, IDMO Acquisition Corp., Idaho Molecular Inc., and Company Representative dated as of December 21, 2021. | Form 8-K (Exhibit 2.1) | 12/23/21 | 001-38148 | ||||||
| 2.1.2 | Amendment to Agreement and Plan of Merger by and among Co-Diagnostics, Inc., Idaho Molecular, Inc., and Kirk Ririe, as Company Representative | Form 8-K (Exhibit 2.2) | 06/16/22 | 001-38148 | ||||||
| 2.2*+ | Agreement and Plan of Merger by and between Co-Diagnostics, Inc, ACI Acquisition Corp., Advanced Conceptions, Inc., and Company Representative dated as of December 21, 2021 | Form 8-K (Exhibit 2.2) | 12/23/21 | 001-38148 | ||||||
| 2.2.1 | Amendment to Agreement and Plan of Merger by and among Co-Diagnostics, Inc., Advanced Conceptions, Inc., and Richard Abbott, as Company Representative | Form 8-K (Exhibit 2.1) | 06/16/22 | 001-38148 | ||||||
| 3.1 | Articles of Incorporation | Draft Registration Statement (Exhibit 3.1) | 01/12/17 | 377-01467 | ||||||
| 3.1.1 | Amendment to the Articles of Incorporation | Draft Registration Statement (Exhibit 3.1.1) | 01/12/17 | 377-01467 | ||||||
| 3.1.2 | Articles of Amendment to Articles of Incorporation | Form 8-K (Exhibit 3.2) | 01/03/19 | 001-38148 | ||||||
| 3.1.3 | Articles of Amendment | Form 10-K (Exhibit 3.1.3) | 03/24/22 | 001-38148 | ||||||
| 3.1.4 | Articles of Amendment | Form 10-K (Exhibit 3.1.3) | 03/16/23 | 001-38148 | ||||||
| 3.1.5 | Certificate of Amendment to the Amended and Restated Certificate of Incorporation of Co-Diagnostics, Inc. | Form 8-K (Exhibit 3.1) | 12/30/25 | 001-38148 | ||||||
| 3.2 | Amended and Restated Bylaws of Co-Diagnostics, Inc. | Form 10-K (Exhibit 3.2) | 03/27/25 | 001-38148 | ||||||
| 4.1 | Description of Registrant’s securities | X | ||||||||
| 4.2 | Form of Indenture | Registration Statement (Exhibit 4.1) | 03/16/23 | 333-270628 | ||||||
| 4.3 | Form of Pre-Funded Warrant | Form 8-K (Exhibit 4.1) | 10/29/25 | 001-38148 | ||||||
| 10.1 | Exclusive Agreement between Co-Diagnostics, Inc. and DNA Logix, Inc., dated April 18, 2014 | Draft Registration Statement (Exhibit 10.2) | 01/12/17 | 377-01467 | ||||||
| 10.2# | Co-Diagnostics, Inc. Amended and Restated 2015 Long Term Incentive Plan | Form S-8/A | 11/20/20 | 333-237684 | ||||||
| 10.3 | Form of Indemnification Agreement | Form S-1/A (Exhibit 10.13.8) | 05/24/17 | 333-217542 | ||||||
| 10.4 | Shareholders’ Agreement between Co-Diagnostics and Synbiotics Limited, dated January 27, 2017 | Form S-1 (Exhibit 10.16) | 04/28/17 | 333-217542 | ||||||
| 10.5 | Amended Exclusive License Agreement between Co-Diagnostics, Brent Satterfield, and DNA Logix, Inc., dated January 1, 2017 | Form S-1 (Exhibit 10.17) | 04/28/17 | 333-217542 | ||||||
| 10.6 | Warrant Agreement between Co-Diagnostics, Inc and VStock Transfer, LLC. Dated December 31, 2021 (ACI Warrant) | Form 10-K (Exhibit 10.6) | 03/24/22 | 001-38148 | ||||||
| 10.7 | Warrant Agreement between Co-Diagnostics, Inc and VStock Transfer, LLC. Dated December 31, 2021 (IDMO Warrant) | Form 10-K (Exhibit 10.7) | 03/24/22 | 001-38148 | ||||||
| 10.9 | Lease Agreement 2401 Foothill Drive | Form 10-K (Exhibit 10.9) | 03/24/22 | 001-38148 | ||||||
| 10.9.1 | Amendment #1 to Lease | Form 10-K (Exhibit 10.9.1) | 03/24/22 | 001-38148 | ||||||
| 10.9.2 | Amendment #2 to Lease | Form 10-K (Exhibit 10.9.2) | 03/24/22 | 001-38148 | ||||||
| 10.10# | Co-Diagnostics, Inc. Change in Control Plan | Form 8-K (Exhibit 10.1) | 05/16/23 | 001-38148 |
| 66 |
| 10.11 | Commercial Lease Agreement, dated June 1, 2023, between Ozone Biotech, LLC and Co-Diagnostics, Inc. | Form 10-Q (Exhibit 10.1) | 08/10/23 | 001-38148 | ||||||
| 10.12 | Commercial Lease Agreement, dated September 18, 2023, between Ge Estate, LLC and Co-Diagnostics, Inc. | Form 10-Q (Exhibit 10.1) | 11/09/23 | 001-38148 | ||||||
| 10.13 | Placement Agency Agreement, dated as of September 17, 2025, by and between the Company and Maxim Group LLC | Form 8-K (Exhibit 1.1) | 09/18/25 | 001-38148 | ||||||
| 10.14 | Form of Securities Purchase Agreement | Form 8-K (Exhibit 10.1) | 09/18/25 | 001-38148 | ||||||
| 10.15 | Equity Distribution Agreement between Co-Diagnostics, Inc. and Maxim Group LLC, dated October 20, 2025 | Form 8-K (Exhibit 10.1) | 10/20/25 | 001-38148 | ||||||
| 10.16 | Form of Securities Purchase Agreement | Form 8-K (Exhibit 10.1) | 10/29/25 | 001-38148 | ||||||
| 10.17 | Placement Agency Agreement, dated as of October 28, 2025, by and between the Company and Maxim Group LLC | Form 8-K (Exhibit 1.1) | 10/29/25 | 001-38148 | ||||||
| 10.18# | Co-Diagnostics, Inc. 2025 Equity Incentive Plan | Form S-8 (Exhibit 10.1) | 01/21/26 | 333-292855 | ||||||
| 14.1 | Code of Ethics for Senior Financial Officers | Form 10-K (Exhibit 14.1) | 03/30/20 | 001-38148 | ||||||
| 19 | Insider trading policies and procedures | Form 10-K (Exhibit 19) | 03/27/25 | 001-38148 | ||||||
| 21.1 | Subsidiaries of Registrant | X | ||||||||
| 23.1 | Consent of Tanner LLC | X | ||||||||
| 31.1 | Certification of Chief Executive Officer pursuant to section 302 of the Sarbanes-Oxley Act of 2002 | X | ||||||||
| 31.2 | Certification of Principal Financial Officer pursuant to section 302 of the Sarbanes-Oxley Act of 2002 | X | ||||||||
| 32.1 | Certification of Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 | X | ||||||||
| 32.2 | Certification of Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 | X | ||||||||
| 97 | Co-Diagnostics, Inc. Clawback Policy | Form 10-K (Exhibit 97) | 03/14/24 | 001-38148 | ||||||
| 101 SCH | Inline XBRL Taxonomy Extension Schema Document (A) | X | ||||||||
| 101.CAL | Inline XBRL Taxonomy Extension Calculation Linkbase Document (A) | X | ||||||||
| 101.DEF | Inline XBRL Taxonomy Extension Definition Linkbase Document (A) | X | ||||||||
| 101.LAB | Inline XBRL Taxonomy Extension Label Linkbase Document (A) | X | ||||||||
| 101.PRE | Inline XBRL Taxonomy Extension Presentation Linkbase Document (A) | X | ||||||||
| 104 | Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101) | X | ||||||||
| (A) | iXBRL (INline Extensible Business Reporting Language) information is furnished and not filed for purposes of Section 11 and 12 of the Securities Act of 1933 and Section 18 of the Securities Exchange Act of 1934. | X |
#Management Contract or Compensatory Plan or Arrangement
*Schedules and exhibits to these Exhibits have been omitted pursuant to Item 601(b)(2) of Regulation S-K. The Company agrees to furnish supplementally a copy of any omitted schedule or exhibit to the SEC upon request.
+ Portions of Exhibit 2.1 and Exhibit 2.2 have been omitted as they contain information that (i) is not material and (ii) is the type of information the issuer both customarily and actually treats as private and confidential.
Item 16. Form 10-K Summary.
None
| 67 |
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
| CO-DIAGNOSTICS, INC. | ||
| Date: March 31, 2026 | By: | /s/ Dwight Egan |
| Dwight Egan | ||
| Chief Executive Officer, President and Director | ||
| (Principal Executive Officer) | ||
| By: | /s/ Brian Brown | |
| Brian Brown | ||
| Chief Financial Officer | ||
| (Principal Financial and Accounting Officer | ||
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the date indicated.
| Signature | Title | Date | ||
| /s/ Dwight Egan | Chief Executive Officer, President and Director | March 31, 2026 | ||
| Dwight Egan | (Principal Executive Officer) | |||
| /s/ Brian Brown | Chief Financial Officer | March 31, 2026 | ||
| Brian Brown | (Principal Financial and Accounting Officer) | |||
| /s/ Eugene Durenard | Director | March 31, 2026 | ||
| Eugene Durenard | ||||
| /s/ Edward Murphy | Director | March 31, 2026 | ||
| Edward Murphy | ||||
| /s/ James Nelson | Director | March 31, 2026 | ||
| James Nelson | ||||
| /s/ Richard Serbin | Director | March 31, 2026 | ||
| Richard Serbin |
| 68 |
FAQ
What does Co-Diagnostics (CODX) identify as its core business?
Why did Co-Diagnostics (CODX) receive a going concern warning?
How is Co-Diagnostics (CODX) funding its operations and R&D?
What are the main regulatory milestones for Co-Diagnostics (CODX)?
How concentrated are Co-Diagnostics’ (CODX) revenues among customers and grants?
What intellectual property protections does Co-Diagnostics (CODX) report?
